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

Model Number	1570-14-070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
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 reported that the device broken in two pieces.
Additional Manufacturer Narrative
Product complaint (b)(4).This is a duplicate report of 1818910-2020-03170.1818910-2020-08285 is being retracted as it is report duplication.1818910-2020-03170 will be kept for investigation purposes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative:  added d10 and h3.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 SZ1 HI 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: 9842943
• Report Number: 1818910-2020-08285
• Device Sequence Number: 13639057
• Product Code: JDI
• UDI-Device Identifier: 10603295060284
• UDI-Public: 10603295060284
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2020

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: 1570-14-070
• Device Catalogue Number: 157014070
• Device Lot Number: D16052152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020; 03/26/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 03/27/2020; 04/01/2020
• 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: C-STEM AMT SZ1 HI OFFSET
• Outcome Attributed to Adverse Event: Required Intervention