MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-32-150
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During the routine radiographic and clinical follow-up, an image compatible with wear/breakage of the polyethylene of the implanted right total hip prosthesis was found.A recommendation for a right pta inspection was therefore placed and performed on (b)(6) 2023 with a finding of broken, disengaged and deformed polyethylene.The ceramic head is also worn with initial signs of metallosis.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary:no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot :a manufacturing record evaluation was performed for the finished device product code:121932150, lot number:574577, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PINN MAR +4 10D 32IDX50OD
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16597659
• Report Number: 1818910-2023-06448
• Device Sequence Number: 14582039
• Product Code: LPH
• UDI-Device Identifier: 10603295014041
• UDI-Public: 10603295014041
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/23/2023

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: 1219-32-150
• Device Catalogue Number: 121932150
• Device Lot Number: 574577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2014
• 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: PINN MAR +4 10D 32IDX48OD.; UNK HIP FEMORAL HEAD CERAMIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown