MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US C-STEM SZ 2 HIGH OFFSET; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	1570-14-085
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	07/29/2020
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
Initially or planned implants: pinnacle cup size 52, poly liner size 52- 32 and corail 11.Cup 52 and poly liner 52- 32 were selected.During surgery surgeon noticed tear in femur and decides to switch to implant a c- stem cemented implant.1 cerclage wire was used to stabilize the crack.C-stem size 2 and 36 +1.5 cup is selected.The discrepancy between the 52 poly liner implant and the 36 cup is not noticed by surgeon, medical staff nor the consulting depuy synthes product specialist during the surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
Additional information received stated that the replacement was due to a fractured neck of femur sustained after a fall from own height.Surgery time was not extended.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Udi : (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.H10 additional narrative: the reported explant date in d7 in the initial submission is now being retracted, as revision did not occur for the stem.

• Brand Name: C-STEM SZ 2 HIGH OFFSET
• Common Device Name: C-STEM HIP IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10415218
• Report Number: 1818910-2020-18250
• Device Sequence Number: 2803106
• Product Code: JDI
• UDI-Device Identifier: 10603295060291
• UDI-Public: 10603295060291
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K003421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/30/2020

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: 1570-14-085
• Device Catalogue Number: 961315000
• Device Lot Number: D20010553
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/12/2020; 08/28/2020; 09/16/2020; 10/12/2020; 10/19/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/18/2020; 08/31/2020; 10/07/2020; 10/16/2020; 10/28/2020
• 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 VOID CENTALIZER 10 DM; C-STEM AMT SZ2 HIGH OFFSET; C STEM VOID CENTALIZER 10 DM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR