MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC SECTOR SERIES 52OD; DURALOC IMPLANT : HIP METAL ACETABULAR CUPS

Catalog Number	124580049
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
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
While reducing hip, duraloc cup with liner came out with stem, surgeon had to change both cup and liner as while extracting liner cup was damaged.
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
There was a surgical delay of 30 minutes.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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: DURALOC SECTOR SERIES 52OD
• 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: 7766857
• Report Number: 1818910-2018-66154
• Device Sequence Number: 2049826
• Product Code: LPH
• UDI-Device Identifier: 10603295019589
• UDI-Public: 10603295019589
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/16/2018

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 Expiration Date: 01/31/2021
• Device Catalogue Number: 124580049
• Device Lot Number: D16021364
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/07/2018; 10/15/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 08/10/2018; 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1