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

Catalog Number	121720044
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent removal surgery.
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: h3, h6: a manufacturing record evaluation was performed for the finished device [product code.121720044/ lot.J26r47] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.Review of the photographic evidence revealed the concave surface near the edge of the pinnacle bantam acet cup 44mm severely worn and scratched.The edge was found fractured and the fragment was not observed in the provided picture.Additionally, foreign matter was observed all over the convex surface of the device.Damage observed on the cup can be traced to an eccentric loading and excessive contact with the head (articul/eze ball 28 +1.5 gr), as a consequence of the fracture of the liner (pinn mar +4 10d 28idx44od).Although the cup failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations, patient changes over time and the extraction process.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.The product was returned to depuy synthes for evaluation.Visual inspection revealed the concave surface near the edge of the pinnacle bantam acet cup 44mm severely carved and the edge was found fractured, the fragment was not returned for evaluation.A few scratches were observed in the concave surface.Additionally, black foreign matter was found all over the convex surface of the device, and a small section of the coating was missing.Damage observed on the cup can be traced to an eccentric loading and excessive contact with the head (articul/eze ball 28 +1.5 gr), as a consequence of the fracture of the liner (pinn mar +4 10d 28idx44od).Although the cup failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations, patient changes over time and the extraction process.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A dimensional inspection and functional testing were not performed as it is not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device [product code.121720044/ lot.J26r47] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinnacle bantam acet cup 44mm would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: PINNACLE
• 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25580183
• Report Number: 1818910-2026-10605
• Device Sequence Number: 9277776
• Product Code: LPH
• UDI-Device Identifier: 10603295009580
• UDI-Public: (01)10603295009580(17)290301(10)J26R47
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: J26R47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown