MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 PINN MAR NEUT 32IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932056
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/01/2018
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
Inlay dislocated.
Additional Manufacturer Narrative
Pc-(b)(4).The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7872624
• Report Number: 1818910-2018-69282
• Device Sequence Number: 228387
• Product Code: LPH
• UDI-Device Identifier: 10603295013921
• UDI-Public: 10603295013921
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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 Catalogue Number: 121932056
• Device Lot Number: 8573834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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