MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932060
Medical Device Problem Codes	Noise, Audible (3273); Separation Problem (4043)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Patient: surgical intervention.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 liner was implanted into the cup system.Over time the liner disassociated from the cup and needed to be revised.The liner was exchanged for a lipped version and the head exchanges for a 32 +9 ceramic ts head.Doi: unknown; dor: (b)(6) 2018; unknown hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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: no anomalies or deviations were found 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).
Event or Problem Description
Patient was also revised due to pain and loud squeaking.

• Brand Name: PINN MAR NEUT 32IDX60OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7955955
• Report Number: 1818910-2018-72144
• Device Sequence Number: 1514632
• Product Code: LPH
• UDI-Device Identifier: 10603295013945
• UDI-Public: 10603295013945
• Combination Product (Y/N): N
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 121932060
• Device Lot Number: HH5689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/13/2018; 12/12/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/20/2018; 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 107