MAUDE Adverse Event Report: DePuy Orthopaedics Inc US PINNACLE POROCOAT; Pinnacle Hip System : Hip Metal Acetabular Cups

Catalog Number	121722052
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a tha revision was performed for a disassociated liner after the patient had fell down while playing pickle ball.The patient was about 3 year post-op on the day of the revision.After exposure and dislocation of the hip, and removal of the femoral head, the surgeon inspected the liner.The liner (altrx 36/52 +4 / 10 degrees) was not really disassociated but rather had broken into a few pieces.The elevated portion of the liner (the 10 degree lip) had broken off, as well as some of the ards.The stem in situ is a corail kla size 13.The femoral head had been rubbing directly against the cup for some time, so there was some intra-articular debris.The surgeon opted to remove the cup and upsize to a size 54.He used an emphasys multi-hole and elevated rim liner.He then used a ts delta ceramic head size 40+5.The corail stem was well fixed and remained in situ.The post x-rays were satisfactory and the patient is in good condition.
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.

• Brand Name: PINNACLE POROCOAT
• Common Device Name: Pinnacle Hip System : Hip Metal Acetabular Cups
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50714410
• Report Number: 1818910-2026-15443
• Device Sequence Number: 10599193
• Product Code: LPH
• UDI-Device Identifier: 10603295009825
• UDI-Public: (01)10603295009825(17)320930(10)M0893R
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 121722052
• Device Lot Number: M0893R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/14/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2022
• 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 Age: 63 YR
• Patient Sex: Female