MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM AMT SZ3 STD OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Catalog Number	157004090
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had primary hip replacement on (b)(6) 2008.Patient complains of leg length discrepancy and once hip was x-rayed showed that the c-stem implant had subsided down the femur.The patient hadn¿t complained of any pain.Once the hip was exposed the femoral implant was removed and polyethylene liner in the acetabulum was replaced from a 32mm to a 36mm and the cement was removed from the femur.The femur was then prepared to accept a reclaim stem and proximal body.Case went straight forward with no issues.Revised stem and acetabulum was very stable at the end of the case.Acetabulum shell was not revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found, no nc¿s associated with this product part#: 157004090, lot#: d16111974 combination.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a search of the depuy nonconformance (nc) quality system found, no nc¿s associated with this product part#: 157004090, lot#: d16111974 combination.

• Brand Name: C-STEM AMT SZ3 STD OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18956351
• Report Number: 1818910-2024-06310
• Device Sequence Number: 9345916
• Product Code: JDI
• UDI-Device Identifier: 10603295059615
• UDI-Public: 10603295059615
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K042959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 03/21/2024

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 Expiration Date: 10/31/2021
• Device Catalogue Number: 157004090
• Device Lot Number: D16111974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/07/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 32MM +5.; PINN MAR NEUT 32IDX56OD.; UNKNOWN CEMENT.; UNKNOWN HIP ACETABULAR CUP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 85 KG