MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 PINN SECTOR W/GRIPTION 64MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121732064
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Synovitis (2094); No Code Available (3191)
Date of Event	05/01/2018
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
Customer is reporting a competitor (link) hip head dia 40 mm to luxate from depuy constrained liner when the ring was still closed.See attached x-rays.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint: (b)(4).Investigation summary: conclusion and justification status: following inspection of the returned products and review of the information received, it was concluded that it was unlikely that a depuy manufacturing defect was present.The complaint shall be closed with an undetermined conclusion, it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.

• Brand Name: PINN SECTOR W/GRIPTION 64MM
• 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: 7675250
• Report Number: 1818910-2018-64163
• Device Sequence Number: 13805284
• Product Code: JDI
• UDI-Device Identifier: 10603295010364
• UDI-Public: 10603295010364
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093646
• 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
• Report Date (Section B): 06/12/2018

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: 121732064
• Device Lot Number: HJ4109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/06/2018
• 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