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

Model Number	1570-14-085
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
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
It was initially reported that implant was received as a blind unit.Revision to address implant fracture post op: metal.Doi: unknown; dor: unknown; hip unknown.Investigations are being conducted.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : visual examination of the received device confirms a material fracture of the femoral stem.The stem was evaluated by a depuy material scientist.No material or manufacturing defects were observed in the femoral stem that could have contributed to fracture initiation and/or propagation to failure.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.Device history lot : a manufacturing record evaluation was performed for the finished device product code 157014085, lot no.D14021418, and no non-conformances/ manufacturing irregularities were identified.Device history review : a manufacturing record evaluation was performed for the finished device product code 157014085, lot no.D14021418, and no non-conformances/ manufacturing irregularities were identified.

• Brand Name: C-STEM AMT SZ2 HIGH 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: 11185533
• Report Number: 1818910-2021-01333
• Device Sequence Number: 2551920
• Product Code: JDI
• UDI-Device Identifier: 10603295060291
• UDI-Public: 10603295060291
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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 Model Number: 1570-14-085
• Device Catalogue Number: 157014085
• Device Lot Number: D14021418
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 12/14 36MM +5
• Outcome Attributed to Adverse Event: Required Intervention