MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC SECTOR SERIES 50OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Catalog Number	124580056
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
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
Size issue.The outer diameter of acetabular cup is too small to implant.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary the returned part was examined by the manufacturer and the device met specification.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, will be filed as appropriate.

• Brand Name: DURALOC SECTOR SERIES 50OD
• Common Device Name: DURALOC IMPLANT : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7934180
• Report Number: 1818910-2018-71299
• Device Sequence Number: 10995416
• Product Code: LPH
• UDI-Device Identifier: 10603295019657
• UDI-Public: 10603295019657
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 124580056
• Device Lot Number: D17041805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 12/06/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/28/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1