MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 C-STEM AMT SZ1 STD OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Catalog Number	157004070
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Surgeon- (b)(6); op date for revision - (b)(6); previous op date: (b)(6) 2017; operation for primary hip was avn of femoral head.Cement/cement hip (stickers attached) returned with pain post hip replacement.X-ray shows cemented stem subsided 2cm implants and cement removed.Pinnacle cup with screws inserted corail stem + 36 head outcome at time of surgery = satisfactory patient consequence? :unknown is the information being submitted for this complaint all the details that are known/available regarding this event? : yes doi: (b)(6) 2017, dor: (b)(6) 2017.
Additional Manufacturer Narrative
Product complaint #: (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, a follow-up medwatch will be filed as appropriate.

• Brand Name: C-STEM AMT SZ1 STD OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7171137
• Report Number: 1818910-2018-50419
• Device Sequence Number: 13682430
• Product Code: JDI
• UDI-Device Identifier: 10603295059592
• UDI-Public: 10603295059592
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K082239
• 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): 12/11/2017

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: 157004070
• Device Lot Number: D16112113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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: 70 YR