MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SIZE 4 REVISION C-STEM X200M; HIP FEMORAL STEM

Catalog Number	961307000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
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 primary surgery was performed on (b)(6) 2009 via tha.It was reported that the revision surgery was performed (date of the revision was unknown) by replacing the cup and head due to the pain.No further information was provided by the hospital.Doi: (b)(6) 2009; dor:unknown; unknown hip.
Additional Manufacturer Narrative
(b)(4).Investigation summary no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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: SIZE 4 REVISION C-STEM X200M
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7395253
• Report Number: 1818910-2018-56621
• Device Sequence Number: 19028853
• Product Code: JDI
• UDI-Device Identifier: 10603295236757
• UDI-Public: 10603295236757
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: 961307000
• Device Lot Number: 2446257
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/28/2018
• 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