MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE BANTAM ACET CUP 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121720044
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 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 the liner wear post-op & device protrude.Patient had pain on walking.The patient underwent total hip replacement procedure at (b)(6) 2020.In (b)(6) 2025 the liner was found to be worn, and the devices were found protrude.Revision surgery completed (b)(6) 2025.Both the head and cup were replaced at revision doi: (b)(6) 2020 dor: (b)(6) 2025.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received,¿ liner wear post-op & device protrude.The patient underwent total hip replacement procedure at (b)(6) 2020.In (b)(6) 2025, the liner was found to be worn, and the devices were found protrude.Currently the patient is waiting for second surgery.¿ product description: pinnacle bantam acet cup 44mm.Product code: 121720044.Lot no: ht7100.Quantity of manufactured: (b)(4).Date of manufacturing: 6-april-2018.Expiry date: 31-march-2028.Ifu reference: n/a.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: pinnacle bantam acet cup 44mm.Product code: 121720044.Lot no: ht7100.Quantity of manufactured: (b)(4).Date of manufacturing: 6-april-2018.Expiry date: 31-march-2028.Ifu reference: n/a.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 and d10.
Event or Problem Description
Additional information received.After investigation, the patient was a 52-year-old female who underwent total hip arthroplasty in (b)(6) hospital on (b)(6) 2020 (the specific diagnosis, height and weight of the patient were unknown).121928144, 121720044 and 136528330 were implanted during the surgery, the surgical process and postoperative rehabilitation were uneventful.In (b)(6) 2025, the patient visited (b)(6) hospital due to walking pain, and x-ray examination revealed that the liner was worn and the femoral head penetrated out to the worn liner edge.The doctor gave the patient a second surgery for revision, and the specific surgical process was unknown.Currently, the patient's pain after walking was improved, and no subsequent adverse event report was received.

• Brand Name: PINNACLE BANTAM ACET CUP 44MM
• 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 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21445993
• Report Number: 1818910-2025-02961
• Device Sequence Number: 7940198
• Product Code: LPH
• UDI-Device Identifier: 10603295009580
• UDI-Public: (01)10603295009580(17)280331(10)HT7100
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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

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: 121720044
• Device Lot Number: HT7100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2018
• 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: DELTA CER HEAD 12/14 28MM +8.5.; PINN MAR +4 10D 28IDX44OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female