MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 1 STD OFFSET; FEMORAL STEM

Catalog Number	101204010
Medical Device Problem Codes	Degraded (1153); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Patient reported pain and x-ray showed lysis around the shaft, and potential partial loosening of the stem.Patient underwent a revision and stem loosening was confirmed and the cone (trunnion) was noted to have completely corroded.The femoral stem was exchanged with a srom stem/sleeve and the femoral head was exchanged.The acetabular cup and liner were not revised and there were no allegations against either implant.Doi: (b)(6) 2021.Dor: (b)(6) 2023.
Event or Problem Description
Additional information received.Ae was reported to nca/bfarm by user: "hip-tep left coc pairing because of coxarthrosis on (b)(6) 2021 in neustadt.Persistent pain and radiological loosening of the stem.Preoperative puncture sterile.Stem change on (b)(6) 2023.Taper completely massively corroded / metallosis.".
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the or dispatcher from the hospital reported an explanation of a device.Actually no further information available the tri-lock bps sz 1 std offset (product code: 101204010/ lot.Number: j9308k) and photo evidence (b)(4) were returned to depuy synthes for evaluation and forwarded to material science for evaluation.Visual analysis revealed that the taper of the femoral stem exhibits damage consistent with fretting and corrosion of the taper.The corrosion appears to have extended to the top of the taper, with an etched appearance of this proximal surface, and portions of the posteroinferior neck.However, there is no enough evidence available to confirm implant loosening.The evidence suggests there was significant movement between the femoral head and hip stem taper over a long period of time.This suggests the ceramic head was not sufficiently seated on the hip stem taper.A dimensional inspection was not performed for the tri-lock bps sz 1 std offset as it is not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device [101204010 / j9308k] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the investigation found sings of corrosion on taper section of the femoral stem.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4), 2) date of manufacture: 2020/11/17, 3) any anomalies or deviations identified in dhr: none, 4) expiry date: 2030/10/31, 5) ifu reference: 101204010.Device history review : a manufacturing record evaluation was performed for the finished device [101204010 / j9308k] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: TRI-LOCK BPS SZ 1 STD OFFSET
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18091591
• Report Number: 1818910-2023-22792
• Device Sequence Number: 14938821
• Product Code: LPH
• UDI-Device Identifier: 10603295000723
• UDI-Public: 10603295000723
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101204010
• Device Lot Number: J9308K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 11/14/2023; 01/18/2024; 03/14/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/28/2023; 01/24/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRI-LOCK BPS SZ 1 STD OFFSET; UNK HIP FEMORAL HEAD CERAMIC; UNK HIP FEMORAL SLEEVE SROM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG