MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526)
Date of Event	02/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Surgeon reported to (b)(6): "hip-tep left side on (b)(6) 2021 in (b)(6).Patient now is transferred by ambulance from the (b)(6) clinic in (b)(6).Presentation there because of subluxation phenomena at the left hip joint.He had never been free of discomfort since the operation.Always when climbing stairs and during certain movements and loads, he had heard a creaking noise and had slight pain.So far, he has had the feeling that the hip joint has jumped out six times, but then located back in on its own.Yesterday renewed subluxation phenomenon when bending, this time with severe pain, again snapping back by itself.He now has a considerable feeling of instability and does not dare to make certain movements.No pain at rest.No trauma.Radiological dislocation of the pe.Revision of head and inlay on (b)(6) 2022 in (b)(6)." doi: (b)(6) 2021.Dor: (b)(6) 2022.Left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was received for examination.Visual examination of the device, confirmed a disassociation of poly liner and acetabular cup.It is evident that the edge of the liner was loaded by the femoral head and patient body weight while implanted, causing the deformation in the rim of the device.Interlock feature edge of the liner denoted three ard tabs sheared off from the liner which is also evidence of the liner having disassociated from the cup.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: a dhr was performed, 1) quantity manufactured: (b)(4) 2) date of manufacture: 05/18/2019 3) any anomalies or deviations identified in dhr: none 4) expiry date: 04/30/2024 5) ifu reference: 090200701 device history review a manufacturing record evaluation was performed for the finished device (121932058/9163859) product and lot numbers, and no non-conformances were identified.

• Brand Name: PINN MAR NEUT 32IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13719690
• Report Number: 1818910-2022-04377
• Device Sequence Number: 5678864
• Product Code: LPH
• UDI-Device Identifier: 10603295013938
• UDI-Public: 10603295013938
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/10/2022

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 Model Number: 1219-32-058
• Device Catalogue Number: 121932058
• Device Lot Number: 9163859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 04/01/2022; 06/21/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 03/31/2022; 04/04/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; CORAIL2 NON COL HO SIZE 14; DELTA CER HEAD 12/14 32MM +1; PINNACLE 100 ACET CUP 58MM; UNK HIP ACETABULAR LINER POLY; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male