MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 PINN MAR NEUT 32IDX56OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121932056
Medical Device Problem Codes	Disassembly (1168); Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 states second left hip revision.The liner displaced from pinnacle cup and was revised.Patient bent over one day and heard a click then felt pain.X-ray shows metal head articulating on pinnacle cup.Metalosis is present.Patient underwent 1st revision on (b)(6) 2017, head and liner revised due to dislodged liner.
Additional Manufacturer Narrative
Additional narrative: no device associated with this report was received for examination.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 32IDX56OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6964721
• Report Number: 1818910-2017-26992
• Device Sequence Number: 1325363
• Product Code: LPH
• UDI-Device Identifier: 10603295013921
• UDI-Public: 10603295013921
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2017

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 Catalogue Number: 121932056
• Device Lot Number: C73384
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 11/20/2017
• 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
• Patient Age: 72 YR