MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN BANTAM W/GRIPTION 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121730044
Medical Device Problem Codes	Disassembly (1168); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Joint Disorder (2373)
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
Dr (b)(6) hospital.Primary: (b)(6) 2015.Revision to be scheduled.X-ray images indicate disassociation.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Changed from a malfunction to serious injury as revision has occurred.
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device finds nothing outward to suggest product error.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 BANTAM W/GRIPTION 44MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7295689
• Report Number: 1818910-2018-54048
• Device Sequence Number: 13926470
• Product Code: LPH
• UDI-Device Identifier: 10603295009948
• UDI-Public: 10603295009948
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121730044
• Device Lot Number: 598932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 02/26/2018; 02/28/2018; 04/11/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/06/2018; 03/19/2018; 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1