MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM SZ1; HIP FEMORAL STEM/SLEEVE

Catalog Number	961161000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Joint Disorder (2373); No Information (3190)
Date of Event	09/18/2017
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
Der states that the patient had a dislocation.The patient underwent the first revision surgery and a pressure point of the neck of the femoral stem was noted on one of the edges of the acetabulum.It is believed that the polyethylene was worn and the head came out.In that first review surgery, the surgeon removed part of the polythene and had to cut in half the remained part of polyethylene, raised the head and placed a new constricted insert.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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.
Event or Problem Description
Complaint description: der states that the patient had a dislocation.The patient underwent the first revision surgery and a pressure point of the neck of the femoral stem was noted on one of the edges of the acetabulum.It is believed that the polyethylene was worn and the head came out.In that first review surgery, the surgeon removed part of the polythene and had to cut in half the remained part of polyethylene, raised the head and placed a new constricted insert.

• Brand Name: C-STEM SZ1
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; suzhou industrial park; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 6968146
• Report Number: 1818910-2017-27244
• Device Sequence Number: 1091010
• Product Code: JDI
• UDI-Device Identifier: 10603295235187
• UDI-Public: 10603295235187
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K982918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2017

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: 961161000
• Device Lot Number: D14043813
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 08/20/2018
• 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: 75 YR