MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DUR DYNAMIC LOCK RING 56 OR 68; HIP ACETABULAR AUGMENT

Catalog Number	124956000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
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
Patient was revised for acute dislocation.The same implants were reimplanted.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Event or Problem Description
Patient was revised for acute dislocation.The same implants were reimplanted.Patient consequence? :yes patient consequence description:dislocation action taken for procedure:revised liner and head for dislocation is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: DUR DYNAMIC LOCK RING 56 OR 68
• Common Device Name: HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7179057
• Report Number: 1818910-2018-50835
• Device Sequence Number: 19071817
• Product Code: LZO
• UDI-Device Identifier: 10603295019787
• UDI-Public: 10603295019787
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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: 124956000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/05/2017; 01/25/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 01/11/2018; 01/26/2018
• 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: 76 YR
• Patient Weight: 88