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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 01/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The literature article entitled, "fractured femoral stems in primary and revision hip arthroplasties revisited: wrightington experience" written by hosam e.Matar, bsc (hons), msc (ed), frcs (tr&orth), veenesh selvaratnam, frcs (tr&orth), tim n.Board, md, frcs (tr&orth), bodo purbach, md, martyn l.Porter, frcs, peter r.Kay, frcs, nikhil shah, frcs (tr&orth) published by journal of arthroplasty published online 18 january 2020 was reviewed.The article's purpose was to present the authors' experience in managing fractured femoral stems over the last 10 years for both primary and revision stems at their tertiary unit focusing on modes of failure and operative techniques.The article presents data set of 35 hips with fractured primary and revision femoral stems that were revised between 2008 and 2018 separated in three groups: primary arthroplasty with composite beam and miscellaneous stems (10 hips; table 1), primary arthroplasty with cemented polished tapered stems (15 hips; table 2), and revision arthroplasty patients (10 hips; table 3).It is noted that depuy and non-depuy stems are listed in all three groups reflected in all three tables.By calculation, the original four charnely stems from table 1 were implanted prior to 1991 as the years to fracture range is 28 to 43 years and the years of revision occurred between 2008 and 2018.Figure 1,2, and 4 provides a radiographic images of fractured depuy stems.Figure 5 provides radiographic images of a (b)(6) year old man with fractured kar (depuy) stem and no dates are provided for the implantation of the primary charnley to determine if it is associated with depuy.Figure 6 provides radiographic image of a fractured unidentified stem.Depuy product(s): charnley elite stems (total qty 2), c-stems (total qty 12), kar stems (total qty 3), reef stem (total qty 1).Adverse events: fractured stems (treated by revision).Figure 5 of a (b)(6) year old with fractured kar stem (counts for 1 of 3 total qty).

Manufacturer Narrative

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.H6 patient code: no code available (3191) used to capture the device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• 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: 10138780
• MDR Text Key: 194703423
• Report Number: 1818910-2020-13620
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 06/22/2020; 06/22/2020
• Supplement Dates FDA Received: 06/23/2020; 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention