MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM AMT SZ2 STD OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Catalog Number	157004085
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	01/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Revision thr: (b)(6), on (b)(6) 2019.Patient was operated on at the beginning of september and had a cemented c-stem hemiarthroplasty operation.The stem has since subsided and required a revision to address a periprosthetic fracture as well as a loose stem due to poor bone quality.The revision operation was a success with a new long stemmed c-stem being placed back in the patient, along with a bipolar head to complete the revision hemiarthroplasty.Surgeon very happy with outcome of operation immediately after completion (details n/a.).
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4) lose of or failure to bond is being retracted since the loosening was at cement to bone interface.
Event or Problem Description
Additional information received indicating that the loosening happened at cement to bone interface.As per sales rep, they are unsure of the cement originally used in the operation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.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: C-STEM AMT SZ2 STD OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9284381
• Report Number: 1818910-2019-114407
• Device Sequence Number: 1865016
• Product Code: JDI
• UDI-Device Identifier: 10603295059608
• UDI-Public: 10603295059608
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 157004085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2019
• Supplement Date Received by Manufacturer: 12/04/2019; 01/07/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/09/2019; 01/07/2020
• 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