MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DUR MAR 10D LNR 32IDX54OD; HIP ACETABULAR INSERT/LINER

Catalog Number	122032154
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/10/2017
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
Patient was revised to address pain in her hip, it was also stated that there was a trunnionosis/metallosis suspected.Update 7/10/2017 der reviewed for reportability decision.An unknown duraloc locking ring was been added to the complaint.The harm for adverse tissue reaction has been removed as it pertains to the competitor product stem and head components.Complaint updated on: 8/8/2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.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 MAR 10D LNR 32IDX54OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6773644
• Report Number: 1818910-2017-22331
• Device Sequence Number: 10796029
• Product Code: LPH
• UDI-Device Identifier: 10603295015543
• UDI-Public: 10603295015543
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K994415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2017

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: 122032154
• Device Lot Number: Y55CT1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 09/06/2017
• 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