SMR ShoulderRecalls & reported problems across all models

We found 67 models of SMR Shoulder by Limacorporate SPA in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2016 and Sep 10, 2026 — classified as 133 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (37 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SMR Shoulder problems

SMR Shoulder models

67 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SMR Shoulder Liner

  Shoulder Prosthesis, Reverse Configuration
  8 reports
• SMR Shoulder Glenosphere

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  8 reports
• SMR Shoulder Liner

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  7 reports
• SMR Shoulder Liner

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  7 reports
• SMR Shoulder Humeral Head

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  6 reports
• SMR Shoulder Reverse Humeral Body

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  5 reports
• SMR Shoulder Liner

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  5 reports
• SMR Shoulder Liner

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  5 reports
• SMR Shoulder Humeral Head

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  4 reports
• SMR Shoulder Liner

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  4 reports
• SMR Shoulder Liner

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  4 reports
• SMR Shoulder Glenosphere

  Shoulder Prosthesis, Reverse Configuration
  4 reports
• SMR Shoulder Glenosphere

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  4 reports
• SMR Shoulder Finned Stem

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  3 reports
• SMR Shoulder Humeral Head

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 reports
• SMR Shoulder Humeral Body

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  3 reports
• SMR Shoulder Liner

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  3 reports
• SMR Shoulder 1360.50.820

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  3 reports
• SMR Shoulder Expansion Extractor

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 reports
• SMR Shoulder 9013.52.147

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 reports
• SMR Shoulder Humeral Head

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 reports
• SMR Shoulder Cemented Glenoid

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 reports
• SMR Shoulder Cemented Glenoid

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 reports
• SMR Shoulder Liner

  Shoulder Prosthesis, Reverse Configuration
  2 reports
• SMR Shoulder Humeral Head (CoCrMo)

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  2 reports
• SMR Shoulder 9013.75.355

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
  2 reports
• SMR Shoulder 1360.54.810

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 reports
• SMR Shoulder 1360.54.820

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
  2 reports
• SMR Shoulder 1352.15.015

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 reports
• SMR Shoulder Finned Stem

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR Shoulder Finned Stem

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR Shoulder Finned Stem

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR Shoulder Finned Stem

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR Shoulder Humeral Head

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Humeral Head

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Eccentrical Adaptor

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Humeral Body

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Humeral Body

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Glenosphere

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Connector + Screw

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Eccentrical Glenosphere

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Finned Trial Stem

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Trial Revision Stem

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR Shoulder Humeral Head (CoCrMo)

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Humeral Head (CoCrMo)

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Liner

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder SMALL-R Baseplate Extractor

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Stem Impactor

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR Shoulder Liner

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR Shoulder Glenosphere

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR Shoulder Resection Jig

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Cemented Glenoid

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Humeral Head (CoCrMo)

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder Trial Stem

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder 1304.15.017

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder 1352.15.051

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
  1 report
• SMR Shoulder 1374.09.131

  Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
  1 report
• SMR Shoulder 1365.54.810

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR Shoulder 1365.54.820

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR Shoulder 1379.59.110

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder 1379.59.330

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR Shoulder 1375.15.507

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder 1375.15.515

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder 1375.15.522

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder 1374.15.322

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR Shoulder 1360.54.821

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
  1 report
• SMR Shoulder 1352.15.051

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report

Recent SMR Shoulder adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Mechanical Problem

  Intra-operative issue occurred on (b)(6) 2026 during shoulder surgery: SMR-TRIAL REV.STEM Ø15MM L=180 (product code 9013.08.156, lot 15AR0H8) got stuck on the SMR- HUMERAL BODY IMPACTOR (product code 9013.52.140, lot 18AR065). The surgery has been performed with another instruments set took from a different hospital, causing a delay to complete the surgery (>29 minutes). No negative consequences for the patient were reported due to this issue.The patient in male, 85 years old.This event occurred in Switzerland.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50711873 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  A shoulder reverse implant revision was performed on (b)(6) 2026 due to infection. A deltoid split approach was used; the liner, humeral body were removed and all signs of infection around the top of the stem were addressed. The glenoid was exposed and the glenosphere was removed. The joint was thoroughly washed out using 4 to 5 bags of 2L saline solution. New implants were then inserted "[?]" glenosphere, liner and humeral body "[?]" followed by a final washout with additional saline prior to closure of the shoulder joint. Previous surgery was performed on (b)(6) 2026.The surgeon followed the standard surgical workflow for shoulder revision. The explanted components included:· REVERSE #SHORT HUM. BODY 140° (Product code 1352.15.015, lot 2601033, ster. n. 2600034).· SMR REV. HP LAT. LINER MEDIUM (Product code 1365.09.115, lot 2530328, ster. n. 2500239).· SMR SMALL/STD CONNECTOR +2 (Product code 1374.15.322, lot 2541225, ster. n. 2600017).· SMR REVERSE HP GLENOSPH. 40 MM (Product code 1374.50.400, lot 2616231, ster. n. 2600105).Patient is Male, 74 years old.Event happened in Australia.

  Patient problems: Medical device site infection

  MAUDE report 50066787 ↗
• InjuryJul 2, 2026Device Dislodged or Dislocated

  REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO SHOULDER DISLOCATION. COMPLETE PATIENT'S CLINICAL HISTORY IS DESCRIBED BELOW. THE PATIENT HAD A FRACTURE OF THE PROXIMAL HUMERUS THAT WAS INITIALLY TREATED WITH AN OPEN REDUCTION AND INTERNAL FIXATION (SURGICAL PROCEDURE TO REPAIR SEVERE BONE FRACTURES USING HARDWARES LIKE SCREWS, PLATES AND/OR RODS). AFTER A FAILURE OF THE ORIF, ON (B)(6) 2026, THE SURGEON OPTED TO PERFORM A REVERSE ARTHROPLASTY USING A COMBINATION OF ALTIVATE REVERSE GLENOID COMPONENTS (FROM OTHER MANUFACTURER) AND SMR SYSTEM ON THE HUMERAL SIDE, CONSISTING OF: REVISION STEM CEMENTED DIA. 13MM H. 210MM (PN 1309.15.138); 140° FINNED REVERSE HUMERAL BODY (PN 1352.15.051); REVERSE LINER DIA. 36MM +6MM (PN 1360.54.820). DURING HEALING PROCESS PATIENT EXPERIENCED SOME SHOULDER INSTABILITY. THEREFORE, A REVISION SURGERY (REPORTED THROUGH MFR 3008021110-2026-00149) OCCURRED ON (B)(6) 2026, WHEN SURGEON REMOVED THE PRE-EXISTING LINER AND REPLACED IT WITH AN EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001) AND A RETENTIVE LINER REVERSE DIA36MM +6MM (PN 1360.54.821) TO INCREASE TISSUE TENSION. ALSO, THE GLENOSPHERE FROM OTHER MANUFACTURER WAS REPLACED WITH NEW ONE. AT THE

  Patient problems: Joint Dislocation

  MAUDE report 25687435 ↗
• InjuryJul 2, 2026Insufficient Device Problem Information

  SHOULDER REVISION SURGERY HAS BEEN PERFORMED ON (B)(6), 2026, DUE TO FAILURE OF GLENOID COMPONENTS. PREVIOUS SURGERY OCCURRED ON (B)(6), 2024, WHEN A REVERSE CONFIGURATION CONSISTING OF BOTH LIMACORPORATE AND ANOTHER MANUFACTURER COMPONENTS WERE IMPLANTED. DURING THE REVISION SURGERY HEREBY REPORTED, THE PRE-EXISTING REVERSE SHOULDER CONFIGURATION WAS CONVERTED TO A HEMIARTHROPLASTY CONFIGURATION, DUE TO FAILURE OF THE GLENOID COMPONENTS PRODUCED BY THE OTHER MANUFACTURER. THE PREVIOUSLY IMPLANTED COMPONENTS, INCLUDING THE SMR REVERSE LINER +6 MM D.40 MM (PN 1365.50.820, LOT. 23AT2PJ, STER. 2400073), WERE EXPLANTED AND FOLLOWING COMPONENTS WERE SUBSEQUENTLY IMPLANTED: · SMR FINNED STEM, DIAMETER 19 MM, LENGTH 80 MM (PN 1304.15.190); · SMR 140° REVERSE HUMERAL BODY (PN 1352.15.011); · SMR ADAPTER 36 MM FOR REVERSE BODY (PN 1352.15.200); · CTA HEAD, DIAMETER 54 MM (PN 1323.09.540). THE PROCEDURE WAS COMPLETED AS INTENDED. THE PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1963. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 25687434 ↗
• InjuryJul 2, 2026Device Dislodged or Dislocated

  REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO SHOULDER DISLOCATION. PRE-EXISTING FOLLOWING COMPONENTS HAS BEEN EXPLANTED: SMR REVERSE LINER +3MM D.40MM (PART NUMBER 1365.50.815, LOT. 23AT24A, STER. 2400018); SMR GLENOSPHERE Ø 40MM (PART NUMBER 1374.09.121, LOT. 2415894, STER. 2400152); SMR CONNECTOR SMALL R (PART NUMBER 1374.15.305, LOT. 2325339, STER. 2300250); AND REPLACED WITH NEW FOLLOWING ONES: SMR REVERSE LINER RETENTIVE +3MM D.40MM (PART NUMBER 1365.50.816); SMR GLENOSPHERE Ø 40MM (PART NUMBER 1374.09.121); SMR CONNECTOR LAT. +4MM SMALL R (PART NUMBER 1374.15.314). PREVIOUS SURGERY HAS BEEN PERFORMED ON (B)(6) 2024. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1943. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25687433 ↗
• InjuryJul 1, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO CUFF FAILURE. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL ASSEMBLY. IN SUBSEQUENT YEARS, THE PATIENT EXPERIENCED SUBSCAPULARIS FAILURE REQUIRING REVISION. DURING THE SURGERY TO ADDRESS THE SUBSCAPULARIS, THE SURGEON DECIDED TO REPLACE THE EXISTING 42MM HUMERAL HEAD (PN 1322.09.420) WITH ADAPTOR TAPER +4MM (PN 1330.15.274) WITH A SMALLER ONE (40MM H13 ECCENTRICAL 2MM HUMERAL HEAD, PN 1321.09.402). THE PRE-EXISTING TRAUMA HUMERAL BODY #MEDIUM (PN 1350.15.010) HAS ALSO BEEN REPLACED WITH A SHORT ONE (PN 1350.15.030). SUBSCAPULARIS WAS REPAIRED; ASSEMBLY WAS REDUCED IN SIZE AND SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1948. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 25680177 ↗
• InjuryJun 22, 2026Packaging Problem

  ON (B)(6) 2026, AN INTRA-OPERATIVE ISSUE OCCURRED DURING A PLANNED RIGHT REVERSE SHOULDER ARTHROPLASTY. THE SURGEON INTENDED TO IMPLANT A SHORT STEM D.17 MM L: 45 MM (PRODUCT CODE: 1304.15.017). DURING THE PROCEDURE, IT WAS IDENTIFIED THAT THE IMPLANT CONTAINED INSIDE THE PACKAGE LABELED AS SMR FINNED STEM SHORT D.17 MM L: 45 MM (PRODUCT CODE: 1304.15.017, LOT: 2535515 - STER: (B)(4)) WAS NOT A SHORT STEM, BUT A STANDARD STEM D.17 MM L: 80 MM (PRODUCT CODE: 1304.15.170 - LOT: UNKNOWN). THEREFORE, A SHORT STEM PACKAGE APPARENTLY CONTAINED A STANDARD STEM INSTEAD OF THE CORRECTLY LABELED IMPLANT. IT WAS REPORTED THAT THE INVOLVED DEVICE (PRODUCT CODE: 1304.15.017, LOT: 2535515 - STER: (B)(4)) WAS RECEIVED STERILE AND SHOWED NO EVIDENCE OF SEAL BREACH. THIS MISMATCH WAS DISCOVERED DURING SURGERY AFTER OPENING AND IMPLANTATION. AS THE IMPLANT HAD ALREADY BEEN INSERTED AT THE TIME THE DISCREPANCY WAS IDENTIFIED, THE STANDARD STEM WAS LEFT IN SITU. THE SURGEON WAS SATISFIED AND THE RESULT WAS GOOD. THERE WAS A DELAY OF 2-3 MINUTES. ACCORDING TO COMPLAINT SOURCES, THE HUMERUS WAS PREPARED FOR A STANDARD STEM, BUT INTRAOPERATIVELY IT WAS THEN SWITCHED TO A SHORT STEM BECAUSE THIS SUITED TH

  Patient problems: Insufficient Information

  MAUDE report 25574644 ↗
• InjuryJun 16, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER INSTABILITY. PATIENT UNDERWENT PRIMARY SURGERY FOR REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2023 WITH THE FOLLOWING ASSEMBLY: FINNED STEM SHORT DIA 19MM (PN 1304.15.019, LOT 2302711, STERILIZATION 2300070). REVERSE HUMERAL BODY (PN 1352.15.010, LOT 2305346, STERILIZATION 2300099). REVERSE LINER STD DIA40 (PN 1365.50.810, LOT 22AT2GY, STERILIZATION 2300054) GLENOID PEG TT SMALL-R #MEDIUM (PN 1375.14.652, LOT 2300712, STERILIZATION 2300050). TT AUGMENTED BASEPLATE 7° S-R DIA27MM (PN 1375.15.507, LOT 2303113, STERILIZATION 2300060). CONNECTOR SMALL-R (PN 1374.15.305, LOT 2308047, STERILIZATION 2300105). GLENOSPHERE DIA40 (PN 1374.09.121, LOT 2305626, STERILIZATION 2300088). AFTER AROUND ONE YEAR THE CONSTRUCT BECAME UNSTABLE AND THE SURGEON REVISED THE PATIENT (MFR 3008021110-2026-00261) REMOVING THE ABOVE MENTIONED CONNECTOR, GLENOSPHERE AND LINER TO IMPLANT A MORE LATERALIZED ASSEMBLY CONSISTING OF: LATERALIZED CONNECTOR +2MM SMALL-R (PN 1374.15.312, LOT 2011107, STERILIZATION 2000241). GLENOSPHERE DIA36MM (PN 1374.09.111, LOT 2407091, STERILIZATION 2400065). REVERSE LINER DIA36 +3MM (PN 1360.50.815, LOT 23AT253, STE

  Patient problems: Joint Laxity

  MAUDE report 25519180 ↗
• InjuryJun 16, 2026Unstable

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 DUE TO SHOULDER INSTABILITY. PATIENT UNDERWENT PRIMARY SURGERY FOR REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2023 WITH THE FOLLOWING ASSEMBLY: FINNED STEM SHORT DIA 19MM (PN 1304.15.019, LOT 2302711, STERILIZATION (B)(4)). REVERSE HUMERAL BODY (PN 1352.15.010, LOT 2305346, STERILIZATION (B)(4)). REVERSE LINER STD DIA40 (PN 1365.50.810, LOT 22AT2GY, STERILIZATION (B)(4)). GLENOID PEG TT SMALL-R #MEDIUM (PN 1375.14.652, LOT 2300712, STERILIZATION (B)(4)). TT AUGMENTED BASEPLATE 7° S-R DIA27MM (PN 1375.15.507, LOT 2303113, STERILIZATION (B)(4)). CONNECTOR SMALL-R (PN 1374.15.305, LOT 2308047, STERILIZATION (B)(4)). GLENOSPHERE DIA40 (PN 1374.09.121, LOT 2305626, STERILIZATION (B)(4)). AFTER AROUND ONE YEAR THE CONSTRUCT BECAME UNSTABLE AND THE SURGEON REVISED THE PATIENT (HEREBY REPORTED) REMOVING THE ABOVE-MENTIONED CONNECTOR, GLENOSPHERE AND LINER TO IMPLANT A MORE LATERALIZED ASSEMBLY CONSISTING OF: LATERALIZED CONNECTOR +2MM SMALL-R (PN 1374.15.312, LOT 2011107, STERILIZATION (B)(4)). GLENOSPHERE DIA36MM (PN 1374.09.111, LOT 2407091, STERILIZATION (B)(4)). REVERSE LINER DIA36 +3MM (PN 1360.50.815, LOT 23AT253, STERILIZATION (B)(4))

  Patient problems: Joint Laxity

  MAUDE report 25519179 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO INFECTION. PRE-EXISTING SMR REVERSE LINER STD 36MM (PN 1360.54.810, LOT 25AT37T, STERILIZATION 2500177) ORIGINALLY IMPLANTED ON (B)(6) 2026 WAS REMOVED AND REPLACED WITH A NEW ONE. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1954. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 25519177 ↗
• InjuryJun 16, 2026Device Dislodged or Dislocated

  REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO MULTIPLE SHOULDER DISLOCATION OVERTIME. COMPLETE PATIENT CLINICAL HISTORY IS FOLLOWING REPORTED: ON (B)(6) 2026, PATIENT UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY WITH SMR HUMERAL COMPONENTS CONSISTING OF: REVISION STEM DIA16MM H 150MM (PN 1308.15.164); SMR 140° HUMERAL BODY REVERSE (PN 1352.15.011); EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001); RETENTIVE LINER +6MM 36MM (PN 1361.50.820). DJO GLENOSPHERE. DURING FIRST REVISION SURGERY, PERFORMED ON (B)(6) 2026, DUE TO DISLOCATION (ALREADY REPORTED WITH MFR 3008021110-2026-00184), ALL ABOVE MENTIONED COMPONENTS WERE REMOVED AND REPLACED WITH SIMILAR ITEMS, WITH EXCEPTION OF A 140° FINNED HUMERAL BODY REVERSE (PN 1352.15.051) AND A RETENTIVE LINER +6MM DIA 40MM (PN 1365.50.821) FOR SIZE COMPATIBILITY WITH THE DJO 40MM/+4MM LATERALIZED GLENOSPHERE THAT HAS BEEN IMPLANTED. AT THE TIME OF THE SECOND REVISION, HEREBY REPORTED AND OCCURRED ON (B)(6) 2026, PATIENT'S IMPLANT WAS CONSISTING OF: REVISION STEM DIA16MM H 150MM (PN 1308.15.164, LOT. 2004055. STER. (B)(4); EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001, LOT. 2519453, STER. (B)(4); 140° FINNED HUMERAL BODY REVERSE (PN

  Patient problems: Joint Dislocation

  MAUDE report 25516464 ↗
• InjuryMay 27, 2026Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY OCCURRED ON (B)(6) 2021, WHEN THE FOLLOWING ANATOMIC ASSEMBLY WAS IMPLANTED: FINNED STEM DIA16MM L80 (PN 1304.15.160), HUMERAL BODY TRAUMA SHORT (PN 1350.15.030, LOT 1508788, STERILIZATION 2100166), ADAPTOR TAPER NEUTRAL (PN 1330.15.270, LOT 2013121, STERILIZATION 2000263), HUMERAL HEAD DIA 42MM (PN 1322.09.420, LOR 1917287, STERILIZATION 1900460), GLENOID METAL BACK SMALL-R (PN 1375.21.005), LINER FOR METAL BACK SMALL-R (PN 1377.50.005, LOT 20AT0XS, STERILIZATION 2000235). AFTER PATIENT DISLOCATION, THE SURGEON DECIDED TO PERFORM A CONVERSION TO REVERSE CONFIGURATION FOR STABILITY. THE ABOVE MENTIONED HUMERAL BODY, ADAPTOR TAPER, HUMERAL HEAD AND LINER FOR METAL BACK WERE REMOVED AND REPLACED WITH HUMERAL BODY REVERSE (PN 1352.14.010), RETENTIVE LINER +6MM (PN 1361.50.820), CONNECTOR LATERALIZED+2MM SMALL-R (PN 1374.15.312) AND GLENOSPHERE DIA36MM (PN 1374.09.111). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1959. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25297977 ↗
• InjuryMay 26, 2026Unstable; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY HEREBY REPORTED HAS BEEN PERFORMED ON (B)(6) 2026, DUE TO UNDERLYING INFECTION, CHRONIC INSTABILITY AND CONSEQUENT DISLOCATION. PATIENT WAS ORIGINALLY IMPLANTED WITH SMR REVERSE PROSTHESIS. ORIGINAL PROSTHETIC ASSEMBLY CONSISTED OF BASEPLATE, LATERALIZED CONNECTOR +4MM, GLENOSPHERE ECCENTRIC DIA 40MM AND SMR HUMERAL BODY REVERSE (PART NUMBER 1352.15.010, LOT UNKNOWN). 9/10 YEARS LATER, FIRST REVISION SURGERY OCCURRED (B)(6) 2025) DUE TO INFECTION: HUMERAL BODY HAS BEEN EXPLANTED AND REPLACED WITH A NEW ONE (COMPLAINT ASSOCIATED TO MFR # 3008021110-2026-00010). ON (B)(6) 2026, SECOND REVISION SURGERY HAS BEEN PERFORMED DUE TO UNKNOWN REASONS (MFR # 3008021110-2026-00241) AND PRE-EXISTING HUMERAL BODY AND GLENOID COMPONENTS HAS BEEN EXPLANTED AND REPLACED WITH NEW ONES. A THIRD REVISION SURGERY OCCURRED ON (B)(6) 2026, DUE TO UNKNOWN REASONS, AND HUMERAL BODY AND GLENOID COMPONENTS, EXCEPT FOR THE BASEPLATE, HAS BEEN EXPLANTED (MFR # 3008021110-2026-00242) AND REPLACED. THEREFORE, AT THE TIME OF THE FOURTH REVISION SURGERY, HEREBY REPORTED, THE IMPLANT WAS CONSISTING OF: STEM ORIGINALLY IMPLANTED 140° HUMERAL BODY REVERSE (PN 1352.15.015, LOT. 2430583, STER. (B)(4);

  Patient problems: Joint Dislocation; Medical device site infection

  MAUDE report 25280182 ↗
• InjuryMay 26, 2026Insufficient Device Problem Information

  REVISION SURGERY HEREBY REPORTED HAS BEEN PERFORMED ON (B)(6) 2026, DUE TO UNKNOWN REASONS. PATIENT WAS ORIGINALLY IMPLANTED WITH SMR REVERSE PROSTHESIS. ORIGINAL PROSTHETIC ASSEMBLY CONSISTED OF BASEPLATE, LATERALIZED CONNECTOR +4MM, GLENOSPHERE ECCENTRIC DIA 40MM AND SMR HUMERAL BODY REVERSE (PART NUMBER 1352.15.010, LOT UNKNOWN). 9/10 YEARS LATER, FIRST REVISION SURGERY OCCURRED ((B)(6) 2025) DUE TO INFECTION: HUMERAL BODY HAS BEEN EXPLANTED AND REPLACED WITH A NEW ONE (COMPLAINT ASSOCIATED TO MFR # 3008021110-2026-00010). ON JANUARY 21ST, 2026, SECOND REVISION SURGERY HAS BEEN PERFORMED DUE TO UNKNOWN REASONS (MFR # 3008021110-2026-00241) AND PRE-EXISTING HUMERAL BODY AND GLENOID COMPONENTS HAS BEEN EXPLANTED AND REPLACED WITH NEW ONES. A THIRD REVISION SURGERY, HEREBY REPORTED, OCCURRED ON (B)(6) 2026, AND PRE-EXISTING HUMERAL BODY AND GLENOID COMPONENTS EXCEPT FOR THE BASEPLATE HAS BEEN EXPLANTED AND REPLACED, INCREASING ALSO LATERALIZATION. SPECIFICALLY, FOLLOWING COMPONENTS HAVE BEEN EXPLANTED: - 140° HUMERAL BODY FINNED REVERSE (PN 1352.15.051, LOT. 2530378, STER. 2500213); - REVERSE LINER +3MM DIA 40MM (PN 1365.50.815, LOT. 23AT24A, STER. 2400018); - GLENOSPHERE ECCENTRIC

  Patient problems: Insufficient Information

  MAUDE report 25278964 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO ROTATOR CUFF FAILURE. PREVIOUS SURGERY OCCURRED ON (B)(6) 2021 FOR A TOTAL SHOULDER ARTHROPLASTY WITH SMR ANATOMIC COMPONENTS: GLENOID METAL BACK STD (PN 1375.21.010, LOT 2100627, STERILIZATION 2100093). LINER FOR METAL BACK STD (PN 1377.50.010, LOT 20AT3K4, STERILIZATION 2100083). FINNER STEM DIA20MM (PN 1304.15.200, LOT 1804199, STERILIZATION 1800137). FINNED HUMERAL BODY (PN 1350.15.110, LOT 2022509, STERILIZATION 2100045). ADAPTOR TAPER ECCENTRICAL (PN 1331.15.274, LOT 2016589, STERILIZATION 2100139). HUMERAL HEAD DIA50 (PPN 1322.09.500, LOT 1503172, STERILIZATION 2100045). DUE TO ROTATOR CUFF FAILURE, THE ORIGINAL IMPLANT HAS BEEN CONVERTED TO A REVERSE CONFIGURATION REMOVING THE ABOVE-MENTIONED HUMERAL HEAD, ADAPTOR TAPER AND LINER FOR METAL BACK AND REPLACING THEM WITH: CONNECTOR+ SCREW SMALL STD (PN 1374.15.310). GLENOSPHERE DIA36MM (PN 1374.09.111). REVERSE HUMERAL BODY (PN 1352.15.010). EXTENSION FOR REVERSE HUMERAL BODY (PN 1352.15.001). REVERSE LINER STANDARD (PN 1360.50.810). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 25278189 ↗

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