MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX58OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121936158
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Scar Tissue (2060); No Consequences Or Impact To Patient (2199); Joint Dislocation (2374)
Date of Event	10/06/2017
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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
The patient was revised to address hip dislocations x3 within a 2 week period.Liner and head removed and scar tissue from the anterior portion of the hip.Also, a constrained liner was implanted and a plua 5 femoral head.Hip was stable on the table.Both stem and cup were well fixed and left in situe.
Additional Manufacturer Narrative
Product complaint # = > pc-(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.Device history lot = > (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
Complaint description: the patient was revised to address hip dislocations x3 within a 2 week period.Liner and head removed and scar tissue from the anterior portion of the hip.Also, a constrained liner was implanted and a plua 5 femoral head.Hip was stable on the table.Both stem and cup were well fixed and left in situe./ | investigation method: / | investigation summary:.

• Brand Name: PINN MAR +4 10D 36IDX58OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7002203
• Report Number: 1818910-2017-28097
• Device Sequence Number: 1051373
• Product Code: LPH
• UDI-Device Identifier: 10603295014607
• UDI-Public: 10603295014607
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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: 121936158
• Device Lot Number: 342128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 11/04/2017
• Supplement Report FDA Received Date: 03/29/2018
• 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: 87 YR
• Patient Weight: 83