TEMA ElbowRecalls & reported problems across all models

We found 15 models of TEMA Elbow by Limacorporate SPA in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2022 and Jul 13, 2026 — classified as 18 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

TEMA Elbow recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 2, 2024Open, Classified

   Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.

   Z-0744-2025 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. Jan 25, 2023Open, Classified

   Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

   Z-1261-2023 · Root cause: Employee error · Recall details · FDA record ↗

Most reported TEMA Elbow problems

TEMA Elbow models

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

• TEMA Elbow 1590.15.010

  Prosthesis, Elbow, Semi-Constrained, Cemented
  2 recalls3 reports
• TEMA Elbow 1590.15.020

  Prosthesis, Elbow, Semi-Constrained, Cemented
  1 recall1 report
• TEMA Elbow 9015.90.006

  Orthopedic Manual Surgical Instrument
  4 reports
• TEMA Elbow 1552.14.020

  Prosthesis, Elbow, Semi-Constrained, Cemented
  2 reports
• TEMA Elbow 1504.14.060

  Prosthesis, Elbow, Constrained, Cemented
  2 reports
• TEMA Elbow 1575.14.010

  Prosthesis, Elbow, Constrained, Cemented
  2 reports
• TEMA Elbow 1504.14.100

  Prosthesis, Elbow, Constrained, Cemented
  1 report
• TEMA Elbow 1552.14.011

  Prosthesis, Elbow, Semi-Constrained, Cemented
  1 report
• TEMA Elbow 1552.14.021

  Prosthesis, Elbow, Constrained, Cemented
  1 report
• TEMA Elbow 1504.14.070

  Prosthesis, Elbow, Semi-Constrained, Cemented
  1 report
• TEMA Elbow 1504.14.090

  Prosthesis, Elbow, Semi-Constrained, Cemented
  1 report
• TEMA Elbow 1504.14.101

  Prosthesis, Elbow, Semi-Constrained, Cemented
  1 report
• TEMA Elbow 1575.14.030

  Prosthesis, Elbow, Constrained, Cemented
  1 report
• TEMA Elbow 1550.15.120

  Prosthesis, Elbow, Semi-Constrained, Cemented
  1 report
• TEMA Elbow 9015.90.008

  Orthopedic Manual Surgical Instrument
  1 report

Recent TEMA Elbow adverse event reports

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

• InjuryJul 13, 2026Insufficient Device Problem Information

  REVISION SURGERY OF ELBOW PROSTHESIS WAS PERFORMED ON (B)(6) 2024 FOR UNKNOWN REASON. COMPLETE PATIENT CLINICAL HISTORY IS SUMMARIZED BELOW. PATIENT UNDERWENT PRIMARY SURGERY IN 2006 FOR FRACTURE WHEN AN ELBOW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WITH A COMPLETE CEMENTLESS TEMA ASSEMBLY CONSISTING OF: - HUMERAL STEM #H7 LEFT (PN 1504.14.070), - HUMERAL BODY LARGE LEFT + SCREW (PN 1550.15.020), - ULNAR STEM #U6 (PN 1575.14.030), - ULNAR BODY LARGE LEFT + SCREW (PN 1552.15.020), - ULNAR LINER LARGE LEFT (PN 1560.50.020). PATIENT BONE QUALITY WAS REPORTED TO BE POOR. AFTER FEW MONTHS, SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 FOR HUMERAL STEM LOOSENING (MFR. 3008021110-2026-00286) AND THE ABOVE MENTIONED HUMERAL COMPONENTS WERE REMOVED AND REPLACED WITH: - HUMERAL STEM #H9 LEFT (PN 1504.14.090), - HUMERAL BODY LARGE LEFT (PN 1550.15.020)., NO INDICATION REGARDING THE CEMENTATION ADOPTED WAS PROVIDED. ONE MONTH LATER, ON (B)(6) 2021, PATIENT WAS REVISED FOR THE THIRD TIME (MFR. 3008021110-2026-00287) FOR LOOSENING OF THE RECENTLY IMPLANTED HUMERAL STEM #H9 WITH A BIGGER STEM (HUMERAL STEM #H10 LEFT, PN 1504.1

  Patient problems: Insufficient Information

  MAUDE report 25797033 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CUSTOM MADE DEVICE WAS REQUESTED FOR A PATIENT WITH SEPTIC LOOSENING OF HUMERAL COMPONENT OF TEMA ELBOW PROSTHESIS DUE TO RHEAUMATOID BONE LOSS. REVISION SURGERY HAS NOT BEEN PERFORMED YET. COMPLETE PATIENT CLINICAL HISTORY IS SUMMARIZED BELOW. PATIENT UNDERWENT PRIMARY SURGERY IN 2006 FOR FRACTURE WHEN AN ELBOW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WITH A COMPLETE CEMENTLESS TEMA ASSEMBLY CONSISTING OF: HUMERAL STEM, #H7, LEFT (PN 1504.14.070); HUMERAL BODY LARGE, LEFT + SCREW, (PN 1550.15.020); ULNAR STEM #U6, (PN 1575.14.030); ULNAR BODY LARGE LEFT + SCREW, (PN 1552.15.020); ULNAR LINER LARGE LEFT, (PN 1560.50.020). PATIENT BONE QUALITY WAS REPORTED TO BE POOR. AFTER FEW MONTHS, SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 FOR HUMERAL STEM LOOSENING (MFR. 3008021110-2026-00286) AND THE ABOVE-MENTIONED HUMERAL COMPONENTS WERE REMOVED AND REPLACED WITH: HUMERAL STEM #H9, LEFT (PN 1504.14.090); HUMERAL BODY LARGE, LEFT (PN 1550.15.020). NO INDICATION REGARDING THE CEMENTATION ADOPTED WAS PROVIDED. ONE MONTH LATER, ON (B)(6) 2021, PATIENT WAS REVISED FOR THE THIRD TIME (MFR. 3008021110-2026-00287) FOR LOOSENIN

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 25797024 ↗
• InjuryJul 13, 2026Insufficient Device Problem Information

  REVISION SURGERY OF ELBOW PROSTHESIS WAS PERFORMED ON (B)(6) 2023 FOR UNKNOWN REASON. PATIENT CLINICAL HISTORY IS SUMMARIZED BELOW. PATIENT UNDERWENT PRIMARY SURGERY IN 2006 FOR FRACTURE WHEN AN ELBOW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WITH A COMPLETE CEMENTLESS TEMA ASSEMBLY CONSISTING OF: - HUMERAL STEM #H7 LEFT (PN 1504.14.070), - HUMERAL BODY LARGE LEFT + SCREW (PN 1550.15.020), - ULNAR STEM #U6 (PN 1575.14.030 LOT 1816847 STER 1900181), - ULNAR BODY LARGE LEFT + SCREW SCREW (PN 1552.15.020 LOT 1714267 STER 1900181), - ULNAR LINER LARGE LEFT (PN 1560.50.020 LOT 16AT1WL STER 1900184). PATIENT BONE QUALITY WAS REPORTED TO BE POOR. AFTER FEW MONTHS, SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 FOR HUMERAL STEM LOOSENING (MFR. 3008021110-2026-00286) AND THE ABOVE MENTIONED HUMERAL COMPONENTS WERE REMOVED AND REPLACED WITH: - HUMERAL STEM #H9 LEFT (PN 1504.14.090), - HUMERAL BODY LARGE LEFT (PN 1550.15.020). NO INDICATION REGARDING THE CEMENTATION ADOPTED WAS PROVIDED. ONE MONTH LATER, ON (B)(6) 2021, PATIENT WAS REVISED FOR THE THIRD TIME (MFR. 3008021110-2026-00287) FOR LOOSENING OF THE RECENTLY IMPLANTED

  Patient problems: Insufficient Information

  MAUDE report 25797023 ↗
• InjuryJul 13, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO HUMERAL STEM LOOSENING IN ELBOW PROSTHESIS. COMPLETE PATIENT CLINICAL HISTORY IS SUMMARIZED BELOW. PATIENT UNDERWENT PRIMARY SURGERY IN 2006 FOR FRACTURE WHEN AN ELBOW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WITH A COMPLETE CEMENTLESS TEMA ASSEMBLY CONSISTING OF: - HUMERAL STEM #H7 LEFT (PN 1504.14.070 LOT 1813880 STER 1900181), - HUMERAL BODY LARGE LEFT + SCREW (PN 1550.15.020 LOT 1714541 STER 1900189), - ULNAR STEM #U6 (PN 1575.14.030 LOT 1816847 STER 1900181), - ULNAR BODY LARGE LEFT + SCREW (PN 1552.15.020 LOT 1714267 STER 1900181), - ULNAR LINER LARGE LEFT (PN 1560.50.020 LOT 16AT1WL STER 1900184). PATIENT BONE QUALITY WAS REPORTED TO BE POOR. AFTER FEW MONTHS, SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 FOR HUMERAL STEM LOOSENING (HEREBY REPORTED) AND THE ABOVE MENTIONED HUMERAL COMPONENTS WERE REMOVED AND REPLACED WITH: - HUMERAL STEM #H9 LEFT (PN 1504.14.090), - HUMERAL BODY LARGE LEFT (PN 1550.15.020). NO INDICATION REGARDING THE CEMENTATION ADOPTED WAS PROVIDED. ONE MONTH LATER, ON (B)(6) 2021, PATIENT WAS REVISED FOR THE THIRD TIME (MFR. 300802111

  Patient problems: Loose body in joint

  MAUDE report 25797022 ↗
• InjuryJul 13, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO LOOSENING OF HUMERAL COMPONENTS OF ELBOW PROSTHESIS. COMPLETE PATIENT CLINICAL HISTORY IS SUMMARIZED BELOW. PATIENT UNDERWENT PRIMARY SURGERY IN 2006 FOR FRACTURE WHEN AN ELBOW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WITH A COMPLETE CEMENTLESS TEMA ASSEMBLY CONSISTING OF: HUMERAL STEM #H7 LEFT (PN 1504.14.070) HUMERAL BODY LARGE LEFT + SCREW (PN 1550.15.020) ULNAR STEM #U6 (PN 1575.14.030 LOT 1816847 STER (B)(4) ULNAR BODY LARGE LEFT + SCREW (PN 1552.15.020 LOT 1714267 STER (B)(4) ULNAR LINER LARGE LEFT (PN 1560.50.020 LOT 16AT1WL STER (B)(4). PATIENT BONE QUALITY WAS REPORTED TO BE POOR. AFTER FEW MONTHS, SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 FOR HUMERAL STEM LOOSENING (MFR. 3008021110-2026-00286) AND THE ABOVE-MENTIONED HUMERAL COMPONENTS WERE REMOVED AND REPLACED WITH: HUMERAL STEM #H9 LEFT (PN 1504.14.090 LOT 1816474 STER (B)(4) HUMERAL BODY LARGE LEFT (PN 1550.15.020 LOT 1714541 STER (B)(4). NO INDICATION REGARDING THE CEMENTATION ADOPTED WAS PROVIDED. ONE MONTH LATER, ON (B)(6) 2021, PATIENT WAS REVISED FOR THE THIRD TIME (HEREBY REPORTED) FOR LO

  Patient problems: Loose body in joint

  MAUDE report 25797021 ↗
• InjuryApr 8, 2026Patient Device Interaction Problem

  UPCOMING ELBOW REVISION SURGERY DUE TO LOOSENING OF ULNAR STEM DISCOVERED IN EARLY (B)(6) 2026. COMPLETE MEDICAL HISTORY OF THE PATIENT IS BELOW DETAILED. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023, AND FOLLOWING TEMA COMPONENTS WERE IMPLANTED: - HUMERAL STEM #H6 (PN 1504.14.061); - HUMERAL BODY SMALL (PN 1550.15.111); - ULNAR LINER SMALL (PN1560.50.011); - ULNAR BODY SMALL (PN 1552.14.011); - ULNAR STEM #U5.5 (PN 1575.14.020); - AXLE SMALL (PN 1590.15.010). ON (B)(6) 2023, PRE-EXISTING ULNAR COMPONENTS WERE REVISED AND REPLACED WITH FOLLOWING ONES: - TEMA ELBOW ULNAR STEM #U5 (PN 1575.14.010, LOT. 2224203, STER. (B)(4)); - TEMA ELBOW ULNAR BODY SMALL (PN 1552.14.011, LOT. 2225795, STER. (B)(4)); - TEMA ELBOW ULNAR LINER SMALL (PN 1560.50.011, LOT. 18AT1RU, STER. (B)(4)); - TEMA ELBOW AXLE SMALL (PN 1590.15.010, LOT. 2303175, STER. (B)(4)). AS A RESULT OF THE LOOSENING OF ULNAR STEM #U5, HEREBY REPORTED, A CUSTOM IMPLANT ((B)(6)) HAS BEEN REQUESTED. DATE OF REVISION SURGERY HAS NOT BEEN DEFINED YET. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1964. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24813213 ↗
• InjuryJan 26, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING. PATIENT WAS SCHEDULED FOR A TRICEPS REPAIR AND SURGEON NOTICED THAT THE HUMERAL STEM LOOSENED. REVISION WAS THEREFORE PERFORMED REPLACING HUMERAL STEM (PN 1504.14.060) AND BODY (PN 1550.15.110) ONLY. SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE INFORMATION OF ORIGINAL IMPLANT. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Loose body in joint

  MAUDE report 24176356 ↗
• InjuryJan 2, 2026Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON (B)(6) 2025 TO EXPLANT A LOOSE HUMERAL STEM. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023 IMPLANTING THE FOLLOWING COMPONENTS: - TEMA HUMERAL STEM #H10 RIGHT (PART NUMBER 15040.14.101, LOT 1816476, STERILIZATION (B)(6)), - TEMA HUMERAL BODY - LARGE RIGHT (PART NUMBER 1550.15.121, LOT 2019808, STERILIZATION (B)(6)), - TEMA ULNAR STEM #U7 (PART NUMBER 1575.14.050, LOT 1906323, STERILIZATION (B)(6)), - TEMA ULNAR BODY LARGE RIGHT (PART NUMBER 1552.14.021, LOT 2225798, STERILIZATION (B)(6)), - TEMA ULNAR LINER LARGE RIGHT (PART NUMBER 1560.50.021, LOT 2018AT1RV, STERILIZATION (B)(6)), - TEMA AXLE LARGE (PART NUMBER 1590.15.020, LOT 2227696, STERILIZATION (B)(6)). ULNAR COMPONENTS WERE REVISED ON (B)(6) 2023, REPLACING THE PRE-EXISTING STEM WITH TEMA ULNAR STEM #U6 (PART NUMBER 1575.14.030, LOT 2100543, STERILIZATION (B)(6)) AND ULNAR BODY, LINER AND AXLE WITH NEW ONES OF THE SAME SIZE. DURING THE LAST SURGERY ON (B)(6) 2025, THE LOOSE HUMERAL STEM HAS BEEN REMOVED AND CUSTOM-MADE DEVICE HAS BEEN REQUESTED DUE TO BONE LOSS AT THE HUMERAL METAPHYSIS. REFERENCE (B)(4) HAS BEEN ASSIGNED TO THE CUSTOM-MADE DEVICE REQUEST. PATIENT IS MALE, DATE OF BIRTH UNKNOWN

  Patient problems: Loose body in joint

  MAUDE report 23943011 ↗
• InjuryDec 12, 2025Unstable; Unstable

  CONVERSION SURGERY PERFORMED ON (B)(6) 2025 DUE TO ELBOW INSTABILITY. THE PRE-EXISTING IMPLANT WAS NOT REMOVED AS THERE WERE NO SIGNS OF BREAKAGE, BUT SURGEON IMPLANTED THE AXLE #SMALL (PART NUMBER: 1590.15.010, LOT: 2504642, STERILIZATION: 2500077) BETWEEN THE HUMERAL AND ULNAR COMPONENTS TO LINK THEM TO IMPROVE STABILITY. THE SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY DATE AND LIST OF IMPLANTED COMPONENTS IS UNKNOWN. PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1950. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 23789533 ↗
• MalfunctionSep 19, 2025Mechanical Problem; Mechanical Problem

  ELBOW REVISION SURGERY PERFORMED ON (B)(6)2025, DUE TO DISASSOCIATION OF COMPONENTS. HUMERAL BODY WITH SAFETY SCREW DISENGAGED FROM MODULAR SPACER. THIS REVISION IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00115. DURING THE REVISION SURGERY, THE FOLLOWING DRIVER FOR 2NM TORQUE LIMITER USED FOR FINAL IMPLANT ASSEMBLY BROKE IN IMPLANTING THE NEW AXLE: SCREWDRIVER SHAFT FOR AXLE (PART CODE 9015.90.006, LOT NUMBER 24BQ0A7). MOREOVER, THE TIP OF A REVISION/CONVERSION AXLE EXTRACTOR DRIVER BROKE INSIDE THE AXLE PREVIOUSLY IMPLANTED WHILE TRYING TO IMPLANT NEW ONE: THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00117. WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION ABOUT THE PATIENT. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094566 ↗
• MalfunctionSep 18, 2025Mechanical Problem; Mechanical Problem

  ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO DISASSOCIATION OF COMPONENTS. HUMERAL BODY WITH SAFETY SCREW DISENGAGED FROM MODULAR SPACER. THIS REVISION IS REGISTERED AS INTERNAL COMPLAINT: (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00115. DURING THE REVISION SURGERY, THE TIP OF THE FOLLOWING REVISION/CONVERSION AXLE EXTRACTOR DRIVER BROKE INSIDE THE AXLE PREVIOUSLY IMPLANTED WHILE TRYING TO IMPLANT NEW ONE: T15 SCREWDR. SHAFT F. AXLE REMOV (PART CODE 9015.90.008, LOT NUMBER: 24BH0JB). MOREOVER, A DRIVER FOR 2NM TORQUE LIMITER USED FOR FINAL IMPLANT ASSEMBLY BROKE IN IMPLANTING THE NEW AXLE: THIS EVENT IS REGISTERED AS INTERNAL COMPLAINT: (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00121. WE DID NOT RECEIVE ANY ADDITIONAL INFORMATION ABOUT THE PATIENT. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082087 ↗
• MalfunctionAug 2, 2025Break; Break

  INTRA-OPERATIVE ISSUE OCCURRED DURING AN ELBOW SURGERY PERFORMED ON (B)(6) 2025. THE SURGEON TRIED LINKING IMPLANTS USING AXLE ON A TOTAL ELBOW ARTHROPLASTY AND TIP OF DRIVER BROKE INSIDE THE AXLE WHILE TRYING TO IMPLANT. NO BROKEN PIECES WERE LEFT IN THE PATIENT. THE INSTRUMENT INVOLVED IN THIS EVENT IS THE FOLLOWING: - SCREWDRIVER SHAFT FOR AXLE (PART CODE 9015.90.006, LOT NUMBER 23BQ096) THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22694126 ↗
• InjuryAug 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO ULNAR LOOSENING. PREVIOUS SURGERY PERFORMED ON (B)(6) 2024. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH NEW ONES: - ULNAR BODY SMALL RIGHT + SCREW (PART CODE 1552.14.011, LOT NUMBER 2308531, STERILIZATION (B)(4). - ULNAR STEM #U7 (PART CODE 1575.14.050, LOT NUMBER 1906323, STERILIZATION (B)(4)). - ULNAR LINER SMALL RIGHT (PART CODE 1560.50.011, LOT NUMBER 19AT1CQ, STERILIZATION (B)(4)). - AXLE #SMALL (PART CODE 1590.15.010, LOT NUMBER 2303175, STERILIZATION (B)(4)). PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1962. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 22694102 ↗
• InjuryMay 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CONVERSION SURGERY TOOK PLACE ON (B)(6) 2025, TO LINK AN AXLE TO A CUSTOM PROMADE COMPONENT IN A TOTAL ELBOW ARTHROPLASTY. THE SURGEON DID NOT REMOVE THE SUSPECTED COMPONENT, AS THERE WERE NO SIGNS OF BREAKAGE OR FRAGMENTATION. THE SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS INSPECTED PRIOR TO USE AND FOUND TO BE ACCEPTABLE. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025. PRODUCT IMPLANTED: AXLE #SMALL (PRODUCT CODE: 9159015010U03, LOT N.: 2435932, STERILIZATION N.: (B)(4)). PATIENT FEMALE, 78 YEARS OLD. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993936 ↗
• InjuryMay 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON MARCH (B)(6) 2025, THE SURGEON LINKED A PREVIOUSLY IMPLANTED PROMADE CUSTOM TOTAL ELBOW ARTHROPLASTY AND AXLE. NOTHING WAS REMOVED. THE AXLE USED DURING SURGERY IS AXLE #LARGE (PRODUCT CODE: 1590.15.020, LOT: 2435933 - STER. (B)(6)) PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025, AND ANOTHER SURGERY (WITHOUT REMOVING ANY COMPONENTS) TOOK PLACE ON (B)(6) 2025 (REPORTED WITH MDR REPORT NUMBER: 3008021110-2025-00021). THE EVENT OCCURRED IN US.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993925 ↗

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