MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-36-452
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
It was reported that the patient had her hip replaced in 2010, the exact date was unknown.This patient came in because of grinding sensation in her hip where x-rays indicated the hip was slipping out and the hip.All was articulating in the rim of the cup.Physician scheduled this patient for a revision and found the hip ball had been articulating on the edge of the poly liner which had fractured and the pinnacle shell has severe damage due to the 36mm cocr femoral head.The wound was full of metal debris due to the wear and was debrided by surgeon.The femoral hip ball, 52mm pinnacle liner, and a pinnacle cup were explanted.A new competitors cup with femoral augments and a depuy ts ceramic femoral head was replaced onto the stem.The summit stem was well fixed and left in situ.No information was available to record about the stem because it was to difficult for the surgeon to read.No surgical delay.Doi: 2010.Dor: (b)(6) 2021.Right hip.
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 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 device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: PINN MAR +4 NEUT 36IDX52OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11216534
• Report Number: 1818910-2021-01694
• Device Sequence Number: 3806117
• Product Code: LPH
• UDI-Device Identifier: 10603295014706
• UDI-Public: 10603295014706
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2021

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: 1219-36-452
• Device Catalogue Number: 121936452
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/11/2021; 02/18/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 01/28/2021; 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +8.5; PINN MAR +4 NEUT 36IDX52OD; PINNACLE SECTOR II CUP 52MM; UNK HIP FEMORAL STEM SUMMIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR