MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C.* 32MM HEAD +5MM; PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS

Catalog Number	853842
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon performed a hip revison, primary hip arthroplasty was performed in 2018.Patient complained of hip slipping, surgeon suspected this was due to the liner being disassociated from the cup.Liner and cup were explanted and replaced with a trident cup.Doi: 2018.Doe: (b)(6) 2024.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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).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.
Event or Problem Description
Additional information was received: no surgical delay.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: according to the information received, ¿surgeon performed a hip revision, primary hip arthroplasty was performed in 2018 where the following implants were used size 11 std corail cementless collared stem, 32mm metal +5mm head, 56x32mm liner, 56mm pinnacle multi hole cup, and 3 pinnacle screws of unknown length.Patient complained of hip slipping, surgeon suspected this was due to the liner being disassociated from the cup.Liner and cup were explanted and replaced with a trident cup.No other information is available¿.The product was not returned to j&j medtech orthopaedics; however photos were provided for review.(b)(4).The photographs attached were reviewed, however they do not depict the involved p.F.C.* 32mm head +5mm.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photographs provided are not representative of the reported device.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 complaint condition.As part of j&j medtech orthopaedics 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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Common Device Name: PFC FEMORAL HEADS (10/12) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19839756
• Report Number: 1818910-2024-16051
• Device Sequence Number: 6900198
• Product Code: KWY
• UDI-Device Identifier: 10603295207634
• UDI-Public: (01)10603295207634
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K893872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 07/26/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 853842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 10/10/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/12/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ALTRX NEUT 32IDX56OD.; PINNACLE MULTIHOLE II CUP 56MM.; UNK HIP BONE SCREW.; UNK HIP BONE SCREW.; UNK HIP BONE SCREW.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown