MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-31-050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Liner which has dislocated and been revised in (b)(6) last year (2022) now the liner had dislocated again and they think it is something wrong with the cup.The first time when they revised the liner it was also a small amount of metallosis, but they did not find any harm on the cup at that time.They are now planning on changing the cup the (b)(6) 2023.The patient got the first implant in (b)(6) 2022, which got revised in (b)(6) 2022.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
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).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.However, based on the observations on the mating liner returned, a disassociation from mating liner could 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: a manufacturing record evaluation was performed for the finished device (121731050/9806278) product and lot numbers, and no non-conformances were identified.Device history review: a manufacturing record evaluation was performed for the finished device (121731050/9806278) product and lot numbers, and no non-conformances were identified.

• Brand Name: PINN 100 W/GRIPTION 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16418060
• Report Number: 1818910-2023-04290
• Device Sequence Number: 3289456
• Product Code: KWA
• UDI-Device Identifier: 10603295010197
• UDI-Public: 10603295010197
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/22/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1217-31-050
• Device Catalogue Number: 121731050
• Device Lot Number: 9806278
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 04/27/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/17/2023; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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 32IDX50OD; UNKNOWN HIP ACETABULAR LINERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown