MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Thrombosis (2100); No Code Available (3191)

Event Date 06/30/2019

Event Type  Injury  

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.(b)(4).

Event Description

The literature article entitled, "titanium trabecular metal acetabular components and s-rom prosthesis with subtrochanteric osteotomy for treating crowe iv developmental dysplasia of the hip" written by libin meng, zhanxiu zhang, lili zhao, zhiqiang jia, kuixiang wang, jiangfeng liu, limin guo, zhiyuan li, and likang zhang published by int j clin exp med 2019;12(6):7753-7759 published online 30 june 2019 was reviewed.The article's purpose was to analyze the titanium trabecular metal acetabular components and srom prosthesis total hip replacement combined with subtrochanteric osteotomy for the treatment of crowe iv developmental dysplasia of the hip (ddh).Data was compiled from 12 patients that are identified within table 1 who received implants between june 2012 and 2017.The table provides leg length discrepancy measurements preop and postop with narrative description providing clarification the measurements are in centimeters measuring the difference between the affected leg in comparison to the unaffected leg.It is noted that patients 1-4, 6-8, and 10-12 still had leg length discrepancies (lld) postop and captured within this complaint.The article does not specify which patient is associated with the generally reported adverse events.All implants were depuy.Figure 1 provides radiographic images preop and postop with no adverse events within caption description.Depuy products: srom stem and sleeve, tm cup, poly liner, unknown material femoral head (assumed).Adverse events: femoral nerve paralysis (recovered automatically after 6 months).Asymptomatic muscular venous thrombosis in lower extremities (no information regarding interventions provided).

Manufacturer Narrative

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: product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10004949
• MDR Text Key: 190607846
• Report Number: 1818910-2020-11418
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1