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

Catalog Number	121731048
Medical Device Problem Codes	Use of Device Problem (1670); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
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.Additional narrative: e3 initial reporter occupation: lawyer.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 patient received hip-tep left.The patient underwent revision due to the hip socket implanted too steeply, the ceramic inlay broke, causing severe pain, impaired movement and squeaking noises and all that strong, lasting for months or so.Increasing pain led to more and more restricted movement and to the use of strong painkillers.Affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description: pinn 100 w/gription 48mm.Product code: 121731048.Lot number: jc4026.Manufacturing date: 11-mar-2021.Expiry date: (b)(6) 2031.Quantity manufactured: 40.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 : product description: pinn 100 w/gription 48mm.Product code: 121731048.Lot number: jc4026.Manufacturing date: 11-mar-2021.Expiry date: (b)(6) 2031.Quantity manufactured: 40.Device history review: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: b5.
Event or Problem Description
Additional information was received and stated that the reaason for revision was due to implant fractured/broken/cracked/chipped.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21552413
• Report Number: 1818910-2025-03657
• Device Sequence Number: 12819065
• Product Code: KWA
• UDI-Device Identifier: 10603295010180
• UDI-Public: (01)10603295010180(17)310228(10)JC4026
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 121731048
• Device Lot Number: JC4026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• 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 9; DELTA CER HEAD 12/14 32MM +1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female