MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US C-STEM SZ4 HIGH OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	9611-72-000
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on an unknown date, the primary surgery was performed with the implants in question.The surgery was completed successfully without any surgical delay.On (b)(6) 2023, it was reported the revision surgery is scheduled on unknown date due to the suspected metal-on-metal.No further information is available.
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.H10 additional narrative: 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).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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Event or Problem Description
Description was revised as follows: it was reported that on an unknown date, the primary surgery was performed via tha for osteoarthritis of the hip with the implants in question.The surgery was completed successfully without any surgical delay.On (b)(6) 2023, it was reported the revision surgery is scheduled on unknown date due to the suspected metal-on-metal.The revision surgery was completed successfully with 120 minutes delay.Based on the condition of the removed implants and the surrounding cement, soft tissue, and bone, the surgeon indicated that metal-on-metal may have occurred due to the stem neck or the interface between the metal head and metal liner.He observed by the naked eye as if there is wear on the distal side from the midpoint of the stem.He also commented that the degeneration of the cement and bone and soft tissue around the proximal portion of the stem raises the suspicion of armd due to mom.The surgeon requests an investigation to determine the degree of wear and deformation compared to the normal products.Cultures and histological examination are being performed in parallel.No further information is available.
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.H10 additional narrative: 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 : the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed wear on metal material.The report allegation can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: C-STEM SZ4 HIGH OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16673052
• Report Number: 1818910-2023-07247
• Device Sequence Number: 6445916
• Product Code: JDI
• UDI-Device Identifier: 10603295235279
• UDI-Public: 10603295235279
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982918
• 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,Followup
• Report Date (Section B): 04/04/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 9611-72-000
• Device Catalogue Number: 961172000
• Device Lot Number: 1890639
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 04/10/2023; 05/05/2023; 06/16/2023; 09/01/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 04/07/2023; 04/14/2023; 05/08/2023; 06/19/2023; 09/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2005
• 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: 9/10 ULTAMET 36MM HEADS +3.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINNACLE MTL INS NEUT36IDX52OD.; PINNACLE MULTIHOLE II CUP 52MM.; UNK CEMENT CMW.; UNK CEMENT CMW.; UNK HIP ACETABULAR LINER METAL.; UNKNOWN HIP FEMORAL HEAD.; UNKNOWN HIP FEMORAL STEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male