MAUDE Adverse Event Report: DePuy Orthopaedics Inc US PINNACLE; Pinnacle Hip System : Hip Poly Acetabular Liners

Catalog Number	121932150
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent primary total hip arthroplasty for acetabular protrusion using a pinnacle acetabular system and a corail femoral stem.Unfortunately, three months after surgery, she was diagnosed with a severe medical condition, and approximately six months after the index procedure, she experienced two episodes of hip dislocation.Surgeon stated should another dislocation occur; revision surgery will be planned.The acetabular component orientation appears to be an important contributing factor to the instability.Given the patient's significant comorbidities and the need to minimize the extent and morbidity of revision surgery, surgeon believes that conversion to a dual mobility construct may represent the safest and most appropriate option for patient.(b)(4) created to capture 2nd event with event date of (b)(6) 2026 and 1st event is captured in (b)(4) with event date of (b)(6) 2026.
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
• Common Device Name: Pinnacle Hip System : Hip Poly Acetabular Liners
• 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: 50406591
• Report Number: 1818910-2026-14422
• Device Sequence Number: 15746524
• Product Code: LPH
• UDI-Device Identifier: 10603295014041
• UDI-Public: (01)10603295014041
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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: 121932150
• Device Lot Number: M40F81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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