SMR SystemRecalls & reported problems across all models

We found 47 models of SMR System by Limacorporate SPA in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between May 2, 2017 and Sep 23, 2026 — classified as 94 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (23 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 System problems

SMR System models

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

• SMR System 1374.50.400

  Shoulder Prosthesis, Reverse Configuration
  4 reports
• SMR System 1374.09.111

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  4 reports
• SMR System 1376.09.031

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  4 reports
• SMR System 1352.15.010

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  4 reports
• SMR System 1360.50.810

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  4 reports
• SMR System 1360.50.815

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  4 reports
• SMR System 1322.09.440

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  4 reports
• SMR System 1365.09.010

  Shoulder Prosthesis, Reverse Configuration
  3 reports
• SMR System 1304.15.180

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  3 reports
• SMR System 1352.15.005

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  3 reports
• SMR System 1377.50.005

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  3 reports
• SMR System 1377.50.010

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  3 reports
• SMR System 1375.15.605

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 reports
• SMR System 1375.21.010

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

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  3 reports
• SMR System 1322.09.460

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 reports
• SMR System 1322.09.480

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 reports
• SMR System 1322.09.520

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  3 reports
• SMR System 1304.15.170

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  2 reports
• SMR System 1304.15.190

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  2 reports
• SMR System 1374.09.105

  Shoulder Prosthesis, Reverse Configuration
  2 reports
• SMR System 1377.50.020

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  2 reports
• SMR System 1361.50.820

  Shoulder Prosthesis, Reverse Configuration
  2 reports
• SMR System 1322.09.500

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 reports
• SMR System 1322.09.540

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  2 reports
• SMR System 1362.09.020

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR System 1362.09.115

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR System 1362.09.120

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR System 1375.14.652

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR System 1375.14.653

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR System 1304.15.110

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR System 1304.15.140

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR System 1304.15.150

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR System 1306.15.160

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR System 1374.15.305

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR System 1374.15.310

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR System 1308.15.154

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR System 1376.09.030

  Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
  1 report
• SMR System 1378.50.010

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR System 1350.15.020

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR System 1350.15.030

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR System 1352.15.001

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR System 1352.15.050

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR System 1375.15.620

  Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
  1 report
• SMR System 1361.50.815

  Shoulder Prosthesis, Reverse Configuration
  1 report
• SMR System 1321.09.424

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• SMR System 1322.09.541

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report

Recent SMR System adverse event reports

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

• InjurySep 23, 2026Unstable

  A revision surgery was performed on (b)(6) 2025 due to implant instability. The surgical approach was restricted in terms of lateralisation on the glenoid side due to the monoblock design of the custom glenoid. Different humeral options were trialled to achieve stability. The surgeon felt that the extension and long lateralised liner were providing excessive length without corresponding lateralisation, potentially contributing to instability. The extension and long lateralised liner were therefore removed and replaced with a long lateralised liner.Previous surgery was performed on (b)(6) 2025. The CMD 25-1154 implant (CMD 25-1154 Monoblock Glenoid, product code 9617.PE.04Z), which had been implanted on (b)(6) 2025, was not revised, together with the humeral body and the stem.The surgeon followed the standard surgical workflow for shoulder revision. The explanted components included:SMR HUMERAL EXTENSION + 9 MM (Product code 1352.15.001, lot 2422607, ster. n. 2400222).SMR REVERSE HP LAT. LINER LONG (Product code 1362.09.120, lot 2422590, ster. n. 2400215).Patient is Male, 81 years old.Event happened in Australia.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865350 ↗
• InjurySep 21, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50838573 ↗
• InjuryJul 29, 2026Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  The complaint source reported that a first-stage shoulder revision surgery was performed on (b)(6) 2026 due to a dislocation. During the procedure, the glenosphere, custom screw, liner, short reverse body, and associated screw were explanted. A new screw from a standard reverse body was inserted into the stem, which was left in situ.According to the surgeon, a possible contributing factor was an infection. The surgeon also noted that the reverse body screw was not fully engaged and that insufficient bone was removed from the area at reverse body / stem connection.A new custom screw has been requested to LimaCorporate for the planned second-stage revision surgery.Hereby the list of devices that were implanted in the previous surgery: SMR REVERSE HUMERAL BODY SHORT (Product Code: 1352.15.005, Lot: 2602989 - Ster: 260004) - Sold in USSMR REVERSE LINER STANDARD (Product Code: 1360.50.010, Lot: 24at2c8 - Ster: 2400162) - Not sold in USSMR ECCENT. GLENOSPHERE Ø 36MM (Product Code: 1376.15.031, Lot: 2601926 - Ster:2600023) - Not sold in USCORTIC.BONE SCREW D.5 L.32 MM (Product Code: 8432.15.032, Lot: 2521662 - Ster: 2500150) - Sold in USCORTIC.BONE SCREW D.5 L.34 MM (Product Code: 8432.15

  Patient problems: Abnormal Vaginal Discharge; Joint Dislocation

  MAUDE report 50069636 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO A FAILED HEMI ANATOMIC IMPLANT. THE SURGEON REMOVED THE ANATOMIC HEAD AND ADAPTOR AND EXCISED THE SUPERIOR EDGE OF THE GLENOID. THE CTA HEAD WAS RE-IMPLANTED WITH THE ADAPTOR IN THE REVERSE POSITION TO ALLOW GREATER CONTACT WITH THE GLENOID RATHER THAN THE ACROMION. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 AND CONSISTED OF A REVISION FOR A FAILED "REVERSE" TO HEMI ARTHROPLASTY, HOWEVER, THE ANATOMIC HEMI CONSTRUCT ENDED UP RESTING ON THE SUPERIOR EDGE OF THE GLENOID. THE SURGEON FOLLOWED THE STANDARD SURGICAL WORKFLOW FOR SHOULDER REVISION. THE EXPLANTED COMPONENTS INCLUDED: SMR HUMERAL HEAD Ø54 MM (PRODUCT CODE 1322.09.540, LOT 1921272, STER. N. 2000414). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT 2503636, STER. N. 2500066). PATIENT IS FEMALE, 76 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 25688243 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2026 DUE TO INFECTION. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL ASSEMBLY. DURING REVISION, THE PRE-EXISTING SMR REVERSE HUMERAL BODY (PN 1352.15.010), REVERSE LINER +3MM (PN 1360.50.815), ECCENTRICAL GLENOSPHERE DIA36MM (PN 1376.09.031) AND CONNECTOR (PN 1374.15.310) HAS BEEN REMOVED AND REPLACED WITH NEW ONES. AN ADDITIONAL BONE SCREW (PN 8420.15.010) HAS BEEN ADDED TO THE BASEPLATE FOR BETTER FIXATION. SURGERY HAS BEEN COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH J(B)(6) 1964. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Medical device site infection

  MAUDE report 25680183 ↗
• InjuryJun 24, 2026Patient Device Interaction Problem

  A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO INFECTION. THE SURGEON GAINED ACCESS TO THE SHOULDER AND COLLECTED MULTIPLE SPECIMENS FROM DIFFERENT ANATOMIES AND TISSUES FOR TESTING. ALL IMPLANTS WERE THEN REMOVED, TISSUE DEBRIDEMENT WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF A ZIMMER CEMENT SPACER WHILE TREATING THE INFECTION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2026. THE SURGEON FOLLOWED THE STANDARD SURGICAL WORKFLOW FOR SHOULDER REVISION. THE EXPLANTED COMPONENTS INCLUDED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT 2430739, STER. N. 2400261); SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT 2511800, STER. N. 2500108); SMR REV. HP LAT. LINER MEDIUM (PRODUCT CODE 1362.09.115, LOT 2505487, STER. N. 2500076); SMR SMALL/STD CONNECTOR +2 (PRODUCT CODE 1374.15.322, LOT 2518095, STER. N. 2500155); SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE 1374.50.440, LOT 2512623, STER. N. 2500093); SMR GLENOID PEG TT S/STD #M (PRODUCT CODE 1375.14.662, LOT 2223558, STER. N. 2300112); SMR GLENOID BASEPLATE SMALL (PRODUCT CODE 1375.15.620, LOT 1701022, STER. N. 2300215); BONE SCREW Ø6,5 H.20 MM (PRODUCT CODE 8420.15.010, LOT 2

  Patient problems: Medical device site infection

  MAUDE report 25606224 ↗
• InjuryJun 22, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO GLENOID LOOSENING IN A STUDY PATIENT. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2026 WHEN THE FOLLOWING ASSEMBLY HAS BEEN IMPLANTED: GLENOID BASEPLATE SMALL-R (PN 1375.15.605, LOT 2536262, STERILIZATION (B)(4)), GLENOID PEG SMALL-R #S (PN 1375.14.651, LOT 2515773, STERILIZATION (B)(4)), 2X BONE SCREW (PN 8420.15.010, LOTS 2530046 AND 2523197, STERILIZATION (B)(4) RESPECTIVELY), CONNECTOR SMALL +2MM (PN 1374.15.312, LOT 2513801, STERILIZATION (B)(4)), REVERSE HP GLENOSPHERE (PN 1374.50.440, LOT 2228852, STERILIZATION (B)(4)), SMR STEMLESS REVERSE CORE #L (PN 1355.14.238, LOT 2119985, STERILIZATION (B)(4)), SMR STEMLESS REVERSE LINER #S (PN 1365.09.445, LOT 2222639, STERILIZATION (B)(4)). NO ADVERSE EVENTS OCCURRED DURING SURGICAL PROCEDURE AND SURGEON USED A DELTO-PECTORAL APPROACH. MIGRATION OF THE BASEPLATE WAS NOTICED IN THE EARLY POST OPERATIVE PERIOD (AROUND 6 WEEKS POST OP). PATIENT WAS OPERATING TRACTORS AGAINST MEDICAL ADVICE. THE WHOLE ASSEMBLY HAS BEEN REMOVED DURING REVISION AND REPLACED WITH DJO ALTIVATE REVERSE. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 25573951 ↗
• InjuryJun 16, 2026Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER PAIN AND INSTABILITY. PATIENT UNDERWENT ORIGINAL SURGERY ON OCTOBER 17TH 2025 WHEN THE FOLLOWING REVERSE PROSTHESIS WAS IMPLANTED: FINNED STEM SHORT DIA 15 (PN 1304.15.015), 140° HUMERAL REVERSE BODY (PN 1352.15.011). REVERSE LINER DIA36MM +3MM (PN 1360.54.815, LOT 24AT62M, STERILIZATION 2500098). METAL-BACK GLENOID SMALL-R (PN 1375.21.005). CONNECTOR+SCREW SMALL-R (PN 1374.15.305, LOT 2520843, STERILIZATION 2500162). GLENOPHERE DIA 36MM (PN 1374.09.111, LOT 2519758, STERILIZATION 2500154). DURING REVISION THE ABOVE MENTIONED LINER, GLENOSPHERE AND CONNECTOR WERE REMOVED AND REPLACED WITH A NEW CONNECTOR, AN ECCENTRICAL GLENOSPHERE DIA36MM (PN 1376.09.031) IN ORDER TO GIVE BETTER RANGE OF MOTION AND DECEASED CHANCES OF ANTERIOR IMPINGEMENT, AND A REVERSE LINER STANDARD (PN 1360.54.810) TO MAKE UP FOR 4MM ECCENTRICITY OF THE GLENOSPHERE. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Implant Pain

  MAUDE report 25519178 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO CONTINUOUS PAIN. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE FAILED DJO GLENOID COMPONENTS RE-ESTABLISH SHOULDER FUNCTIONALITY WITH A HEMIARTHROPLASTY CONSISTING OF: HUMERAL BODY REVERSE (PN 1352.15.010, LOT 2509312, STERILIZATION (B)(4) ADAPTOR 36MM FOR REVERSE BODY (PN 1352.15.200, LOT 2307639, STERILIZATION (B)(4) HUMERAL HEAD DIA 48MM (PN 1322.09.480, LOT 2410912, STERILIZATION (B)(4). ORIGINAL STEM WAS LEFT IN PLACE. DUE TO CONTINUOS PAIN AND SEVERE BONE DEFICIENCY OF PATIENT ANTERIOR GLENOID (TEMPORARY PACKED WITH BONE GRAFT DURING PREVIOUS SURGERY), CUSTOM MADE IMPLANT (CMD 26-1040) HAS BEEN REQUESTED FOR AN AUGMENTED GLENOID REVERSE CONFIGURATION WITH CORACOID SUPPORT. REVISION SURGERY TO FINALLY IMPLANT THE CUSTOM MADE DEVICE HAS BEEN SUCCESSFULLY COMPLETED ON (B)(6) 2026 (HEREBY REPORTED): ABOVE MENTIONED HUMERAL COMPOENTS HAVE BEEN REMOVED AND REPLACED WITH NEW HUMERAL BODY REVERSE SHORT (PN 1352.15.005) AND REVERSE LINER +3MM (PN 1360.50.815), WHILE ON THE GLENOID SIDE THE CUSTOM MONOBLOCK GLENOID (PN 9618.14.20M - CMD 26-1040) WITH DJO GLENOSPHERE (RSP GLENOID HEAD 36MM +2MM LATERAL OFFSET) HAVE BEEN PROP

  Patient problems: Implant Pain

  MAUDE report 25297979 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO ROTATOR CUFF FAILURE. PREVUOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE SURGEON EXPLANTED THE PRE-EXISTING TT HYBRID CEM. GLENOID STD LOW (PART NUMBER 1379.59.200), SMR HUMERAL BODY (PN1350.15.010), SMR ECC.ADAPTOR TAPER STD +2M (PART NUMBER 1330.15.272) AND THE SMR HUMERAL HEAD D.52 MM (PART NUMBER 1322.09.520) AND CONVERTED THE PROSTHESIS TO A REVERSE CONFIGURATION USING FOLLOWING COMPONENTS: TT HYBRID REVERSE BASEPLATE STD (PN 1379.15.170), GLENOSPHERE DIA40 (PN 1374.09.121), 140° REVERSE HUMERAL BODY (PN 1352.15.011), EXTENSION FOR HUMERAL REVERSE BODY (PN 1352.15.001), REVERSE LINER STD DIA40 (PN 1365.50.810)., THE DISTAL PORTION OF THE SMR CONSTRUCT WAS LEFT IN PATIENT FOR THE CONVERSION SINCE IT WAS WELL FIXED AND INTACT. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 25297978 ↗
• 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 +4 MM, GLENOSPHERE ECCENTRIC DIA 40 MM 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, HEREBY REPORTED SECOND REVISION SURGERY HAS BEEN PERFORMED AND PRE-EXISTING HUMERAL BODY (PN 1352.15.010, LOT. 2511798, STER. 2500105) AND GLENOID COMPONENTS HAS BEEN EXPLANTED AND REPLACED WITH THE FOLLOWING: 140° HUMERAL BODY FINNED REVERSE (PN 1352.15.051); REVERSE LINER + 3 MM DIA 40 MM (PN 1365.50.815); GLENOSPHERE ECCENTRICAL DIA 40 MM (PN 1376.09.041); CONNECTOR + SCREW (PN 1374.15.305); TT BASEPLATE (PN 1375.15.305); BONE SCREW (PN 8420.15.050); BONE SCREW (PN 8420.15.030). PATIENT IS MALE, DATE OF BIRTH (B)(6) 1962. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 25278965 ↗
• InjuryMay 26, 2026Detachment of Device or Device Component; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2026 BECAUSE OF GLENOID COMPONENTS FAILURE DUE TO BAD PLACEMENT. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION THE PRE-EXISTING METAL BACK GLENOID STD (PN 1375.21.010), GLENOSPHERE ECCENTRICAL DIA36MM (PN 1376.09.030) AND SMR REVERSE LINER STANDARD (PN 1360.50.810) WERE REMOVED AND THE ASSEMBLY WAS CONVERTED TO A HEMIARTHROPLASTY WITH AN ADAPTOR 36MM FOR REVERSE BODY (PN 1352.15.200) AND CTA HEAD DIA50MM (PN 1323.09.500). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 25278198 ↗
• InjuryMay 26, 2026Mechanical Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 BECAUSE OF FAILURE OF REVERSE SHOULDER ASSEMBLY DUE TO MALALIGNMENT. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL PROSTHESIS. DURING REVISION, THE ORIGINAL METAL BACK (PN 1375.21.010) AND GLENOSPHERE DIA36MM (PN 1376.09.030) WERE REMOVED, AS WELL AS REVERSE LINER STANDARD (PN 1360.50.810), TO BE REPLACED WITH DIFFERENT MANUFACTURER REVERSE GLENOID ASSEMBLY. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 25275493 ↗
• InjuryMay 18, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO SHOULDER DISLOCATION. PREVIOUS SURGERY OCCURRED ON (B)(6) 2025 WHEN ORIGINAL ANATOMIC PROSTHESIS WAS CONVERSED TO A REVERSE CONFIGURATION DUE TO ROTATOR CUFF FAILURE (PREVIOUSLY REPORTED WITH MFR. 3008021110-2026-00073). PATIENT DISLOCATED AND THE SURGEON DECIDED TO PERFORM A REVISION SURGERY SINCE THEY COULD NOT REDUCE THE DISLOCATION OF THE REVERSE IN OTHER WAY. DURING REVISION, THE PRE-EXISTING SMR SMALL/STD CONNECTOR +2MM (PN 1374.15.322, LOT 2514593, STERILIZATION (B)(4), GLENOSPHERE Ø 36MM (PN 1374.09.111,LOT 2515422, STERILIZATION 2500135) AND SMR REVERSE LINER + 6 MM (PN 1360.50.820, LOT 23AT40J, STERILIZATION 2400057) WERE REMOVED AND REPLACED WITH NEW CONNECTOR, ECCENTRICAL GLENOSPHERE DIA40MM (PN 1376.09.041) AND REVERSE LINER RETENTIVE +3MM (PN 1365.50.816). REVERSE LINER WAS FOUND DISSOCIATED FROM HUMERAL BODY DURING REVISION. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6) 1951. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Dislocation

  MAUDE report 25200759 ↗
• InjuryMay 4, 2026Detachment of Device or Device Component

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO DISASSEMBLY OF COMPONENTS AND METALLOSIS. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE PRODUCT INFORMATION OF ORIGINAL IMPLANT. DURING REVISION, THE PRE-EXISTING LINER FOR METAL BACK GLENOID SMALL (PN 1377.50.020) WAS FOUND LOOSE FROM THE SMR METAL-BACK GLENOID SMALL (PN 1375.21.020) AND FLOATING IN THE JOINT, CAUSING METAL ON METAL FRICTION AND THEREFORE SEVERE METALLOSIS. SURGEON REMOVED ALL THE GLENOID COMPONENTS, AS WELL AS THE PRE-EXISTING SMR HUMERAL HEAD Ø50 MM (PN 1322.09.500) AND ADAPTOR TAPER (PN 1330.15.274) AND RE-IMPLANTED A NEW TAPER AND HEAD ON THE HUMERAL SIDE TO RESTORE SHOULDER FUNCTIONALITY WITH A HEMI ARTHROPLASTY. SURGERY WAS COMPLETED AS INTENDED. PATIENT IS MALE, DATE OF BIRTH (B)(6)1960. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Loose body in joint; Metal Related Pathology

  MAUDE report 25067102 ↗

Other Limacorporate SPA products

• PRIMA TT Glenoid16 models · 11 reports · 3 recalls
• SMR Shoulder67 models · 148 reports
• TEMA Elbow15 models · 23 reports · 2 recalls
• PRIMA4 models · 4 reports · 2 recalls
• SMR TT Hybrid Glenoid3 models · 2 reports · 1 recall