MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-31-048
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	01/10/2023
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
Surgeon sent an email directly to complaint handling unit: he reported about an marathon inaly damage.Revision of inlay component on (b)(6) 2023.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A manufacturing record evaluation was performed for the finished device [121731048 / 9690154] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.1) quantity manufactured: (b)(4).2) date of manufacture: 30/jan/2021.3) any anomalies or deviations identified in dhr: there were no non-conformances associated with this lot related to the malfunction.4) expiry date: 31/dec/2030.5) ifu reference: 090200701.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 : 1) quantity manufactured: (b)(4).2) date of manufacture: 30/jan/2021 3) any anomalies or deviations identified in dhr: there were no non-conformances associated with this lot related to the malfunction.4) expiry date: 31/dec/2030 5) ifu reference: 090200701.Device history review : a manufacturing record evaluation was performed for the finished device [121731048 / 9690154] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.
Event or Problem Description
Additional information received indicated that there was no surgical delay reported.The patient noticed "cracking" at the area of the right hip since about 4 months.The pain extends to the spine.No known trauma.After implantation of a right hip.
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.

• Brand Name: PINN 100 W/GRIPTION 48MM
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16252689
• Report Number: 1818910-2023-02177
• Device Sequence Number: 19655684
• Product Code: KWA
• UDI-Device Identifier: 10603295010180
• UDI-Public: 10603295010180
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 01/27/2023
• 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: 1217-31-048
• Device Catalogue Number: 121731048
• Device Lot Number: 9690154
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 03/29/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/21/2023; 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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: APEX HOLE ELIM POSITIVE STOP.; CORAIL2 STD SIZE 10.; HIP BALL BIOLOX 32 +1 12/14.; PINN MAR +4 10D 32IDX48OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female