MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 28IDX46OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928146
Medical Device Problem Codes	Naturally Worn (2988); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This case is from the health authority.One year after surgery, the inner lining was severely worn and there was a clicking sound during movement, accompanied by pain.Later, the patient was admitted to the hospital.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.H11 additional narrative: added: b5.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 received: after investigation, the patient underwent total hip replacement surgery in the hospital due to femoral neck fracture on (b)(6) 2024.(b)(6) was implanted during the surgery.The hospital reported that the surgery went smoothly, the postoperative rehabilitation of the patient was unknown, and the patient often had squatting action in daily life.One year after the surgery, it was found that the patient's liner showed severe wear, and there was a clicking sound during movement, accompanied by pain.The doctor performed a second surgery to remove the implant in advance.During this period, the bacterial culture result was negative the specific samples and examination items were unknown.The patient was in stable condition now, and no subsequent adverse event report was received.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Corrected: e1 facility name.

• Brand Name: PINN MAR +4 10D 28IDX46OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23657620
• Report Number: 1818910-2025-20785
• Device Sequence Number: 9962067
• Product Code: LPH
• UDI-Device Identifier: 10603295013440
• UDI-Public: (01)10603295013440
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 121928146
• Device Lot Number: M2351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/17/2025; 02/21/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/18/2025; 02/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown