MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 NEUT 44IDX62OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121944462
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/29/2017
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
The patient was revised to address dislocation and stem loosening.Update: (b)(6) 2017 records reviewed.Added unknown femoral head to the complaint to address the reported dislocation.Cement manufacturer is currently unknown.Reportedly, the femoral construct was easily removed as a unit, covered in cement, but it is noteworthy that the cement did not appear to have adhered to the bone at all.This indicates a failure at the bone to cement interface.Complaint updated on: (b)(6) 2017.
Additional Manufacturer Narrative
The patient was revised to address dislocation and stem loosening.The reported event has been evaluated and will be monitored.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: PINN MAR +4 NEUT 44IDX62OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6897094
• Report Number: 1818910-2017-25478
• Device Sequence Number: 18974982
• Product Code: LPH
• UDI-Device Identifier: 10603295014935
• UDI-Public: 10603295014935
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: 121944462
• Device Lot Number: 384133
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 11/15/2017
• 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
• Patient Age: 70 YR