MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE GRIPTION; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121731060
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to instability.Cup appears to be vertical and overly anteverted.Patient also has spinal/pelvic issues.Doi: (b)(6) 2026.Dor: (b)(6) 2026.Affected side: left hip.
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 medwatch, a follow-up medwatch will be filed as appropriate.
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 60mm.Product code: 121731060.Lot number: m55r69.Date of manufacturing: 14 - february - 2024.Expiry date: 31 - january - 2034.Quantity to be manufactured: (b)(4).A manufacturing record evaluation was performed for the finished device product description: pinn 100 w/gription 60mm, product code: 121731060, lot number: m55r69, and no non-conformances / manufacturing irregularities were identified.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 60mm.Product code: 121731060.Lot number: m55r69.Date of manufacturing: 14 - february - 2024.Expiry date: 31 - january - 2034.Quantity to be manufactured: (b)(4).Added : d10 concomitant.

• Brand Name: PINNACLE GRIPTION
• 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: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24983887
• Report Number: 1818910-2026-07560
• Device Sequence Number: 10505635
• Product Code: KWA
• UDI-Device Identifier: 10603295010241
• UDI-Public: (01)10603295010241(17)340131(10)M55R69
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 121731060
• Device Lot Number: M55R69
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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: ALTRX +4 NEUT 36IDX60OD; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male