MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR NEUT 28IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928052
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671)
Date of Event	01/01/2018
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
Direct contact between the head and the acetabulum (pinnacle).That led to change in the shape of the polyethylene insert and breakage of 4 spines.Action taken was the head and the insert was changed.Primary surgery date was on (b)(6) 2017.
Event or Problem Description
Instability in walking.
Additional Manufacturer Narrative
(b)(4).Examination of the acetabular liner does find evidence to support the reported disassociation event.Product error / contribution to the event is not identified.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MAR NEUT 28IDX52OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7717675
• Report Number: 1818910-2018-65128
• Device Sequence Number: 16476021
• Product Code: LPH
• UDI-Device Identifier: 10603295013303
• UDI-Public: 10603295013303
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/26/2018

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: 121928052
• Device Lot Number: C41986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 09/03/2018; 12/12/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/22/2018; 09/12/2018; 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention