MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121701050
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the patient experienced pain and discomfort after implantation of a hip-tep.Regarding the cup and apex hole eliminator, the patient was given unsuitable parts (thread diameter too large), jamming, etc.The patient has had pain in this leg for almost six years, on the side of the hip, even when turning at night, there's no visible loosening.The patient's walking distance has also shortened.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description-pinnacle 100 acet cup 50mm.Product code-121701050.Lot no- 9272257 quantity of manufactured- (b)(4).Date of manufacturing-03 sep 2019 expiry date: 31 aug 2029.Ifu #: 090200701 ifu tot hip pros.Due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.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 100 acet cup 50mm.Product code-121701050.Lot no- 9272257.Quantity of manufactured- (b)(4).Date of manufacturing-03 sep 2019 expiry date: 31 aug 2029.Ifu #: 090200701 ifu tot hip pros.Device history review: a manufacturing record evaluation was performed for the finished device [lot/serial/batch] number, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PINNACLE 100 ACET CUP 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22135310
• Report Number: 1818910-2025-08956
• Device Sequence Number: 8437215
• Product Code: LPH
• UDI-Device Identifier: 10603295008545
• UDI-Public: (01)10603295008545(17)20290831(10)9272257
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• 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: 121701050
• Device Lot Number: 9272257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2019
• 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: ARTICUL/EZE BALL 32 +1 GR; CORAIL2 STD SIZE 8; PINN MAR +4 NEUT 32IDX50OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female