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

Catalog Number	121701050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	06/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent total hip arthroplasty (tha) on (b)(6) 2024.The then presented to the emergency department on (b)(6) 2026, complaining of severe pain in the left hip which had worsened significantly since the previous evening.Weight-bearing on the left leg was barely possible; the patient denied any preceding trauma.The patient had repeatedly noticed a "grinding" or "popping" sensation in the left hip while walking.An earlier consultation on (b)(6) 2026, due to increasing hip discomfort, had revealed no radiological or ct evidence of prosthesis loosening, periprosthetic fracture, or inlay dislocation.At that time, the femoral head appeared properly centered within the acetabular component.Current diagnostic imaging revealed an eccentric position of the prosthetic head within the acetabular component.Ct findings raised suspicion of inlay dislocation or a material defect in the hip prosthesis.Additionally, an extensive periprosthetic fluid collection containing air pockets was noted.However, clinical and laboratory findings showed no evidence of an acute infection.Based on these findings, an indication for emergency surgical revision was established.Cup, head, and inlay were revised.Intraoperative findings revealed complete dislocation of the inlay, with the ceramic head in direct contact with the acetabular component.The acetabular component showed marked abrasion and significant material destruction but no signs of loosening.It is assumed that the inlay dislocation was not yet present at the time of the consultation on (b)(6) 2026.However, the intraoperative findings indicate a pre-existing degenerative process that ultimately led to complete inlay dislocation and acute pain symptoms.
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.Additional narrative: a2: patient was born in 1968.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.

• 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: 50045238
• Report Number: 1818910-2026-12774
• Device Sequence Number: 9617549
• Product Code: LPH
• UDI-Device Identifier: 10603295008545
• UDI-Public: (01)10603295008545
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: M68W09
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 07/28/2026; 08/11/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 07/29/2026; 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female