MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 C-STEM SZ7; C-STEM HIP IMPLANT : HIP FEMORAL STEM

Model Number	9611-67-000
Medical Device Problem Code	Malposition of Device (2616)
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
This pc related to (b)(4).(b)(4) reported 1st revision surgery.(b)(4) reported 2nd revision surgery.The primary surgery was performed on (b)(6) 2018 via tha.After that, the 1st revision surgery was performed on (b)(6) 2018 (it was reported (b)(4)).2nd revision surgery was performed on (b)(6) 2019 (it was reported (b)(4)).It was reported that 3rd revision surgery was scheduled on (b)(6) 2020 by replacing the cup (p/n: unknown), the head (p/n: 962711000) and the stem (p/n: 961167000) due to loosening of acetabular roof side.At first, the surgeon planned to remain the stem, but the stem was anteversion slightly and to considered working space, he decided to remove the stem.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.H10 additional narrative: corrected h6 patient code: no code available (3191) from the initial medwatch to capture patient harm insufficient information.

• Brand Name: C-STEM SZ7
• 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: 10149246
• Report Number: 1818910-2020-13722
• Device Sequence Number: 2094219
• Product Code: LZO
• UDI-Device Identifier: 10603295235248
• UDI-Public: 10603295235248
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2020

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: 9611-67-000
• Device Catalogue Number: 961167000
• Device Lot Number: D16051166
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/13/2020
• 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: 9/10 ULTAMET 36MM HEADS +0.; C-STEM CENTRALIZER.; C-STEM PMMA END CAP.; C-STEM SZ7.; COMPETITORS PRODUCT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR