MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DUR DYNAMIC LOCK RING 62 OR 74; DURALOC IMPLANT : HIP ACETABULAR AUGMENT

Catalog Number	124962000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Not Applicable (3189)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Der states that duraloc poly was revised for poly wear and broken locking ring.The ring had escaped the shell and was found in the lateral thigh soft tissue.When attempting to implant a new locking ring, it was determined that the duraloc shell was a 60, not a 62.The 62 had been implanted on (b)(6) 2017 based on retrieval of a 62 liner at that time.That liner apparently was implanted on (b)(6) 2000 at (b)(6).The original surgery was done in (b)(6) around 1995.The duraloc shell was revised.Doi: (b)(6) 2017; dor: (b)(6) 2018; left hip.Cup doi: unknown.
Additional Manufacturer Narrative
Product complaint :(b)(4).Investigation summary :no device associated with this report was received for examination.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: DUR DYNAMIC LOCK RING 62 OR 74
• Common Device Name: DURALOC IMPLANT : HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7591910
• Report Number: 1818910-2018-61936
• Device Sequence Number: 19256978
• Product Code: KWA
• UDI-Device Identifier: 10603295019817
• UDI-Public: 10603295019817
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 124962000
• Device Lot Number: 123655
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/19/2018
• 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
• Patient Age: 80 YR