MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.18189810 9/10 COCR HEAD 22.225MM -3; HIP FEMORAL HEAD

Catalog Number	152190051
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Joint Dislocation (2374)
Date of Event	08/16/2017
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 possibly induced by armd.The surgeon commented that if the dislocation would happen again they would perform the 2nd revision to replace the stem with a new implant.
Additional Manufacturer Narrative
Depuy considers the investigation closed at this time.Should the 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.
Additional Manufacturer Narrative
The patient was revised to address dislocation possibly induced by armd.The surgeon commented that if the dislocation would happen again they would perform the 2nd revision to replace the stem with a new implant.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: 9/10 COCR HEAD 22.225MM -3
• Common Device Name: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.18189810; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6866410
• Report Number: 1818910-2017-24678
• Device Sequence Number: 656709
• Product Code: JDI
• UDI-Device Identifier: 10603295276562
• UDI-Public: 10603295276562
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K871867
• 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,Followup
• Report Date (Section B): 08/16/2017

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: 152190051
• Device Lot Number: XHH-81
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 09/27/2017; 12/14/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 09/27/2017; 12/15/2017
• 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