MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL STEM; UNK KNEE FEMORAL STEM

Catalog Number UNK KNEE FEMORAL STEM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Migration (4003)

Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 02/29/2012

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, "mid- to long-term results of revision total knee replacement using press-fit intramedullary stems with cemented femoral and tibial components" written by p.Manopoulos, e.Havet, o.Pearce, j.F.Lardanchet, and p.Mertl published by the journal of bone and joint surgery accepted by publisher 29 february 2012 was reviewed.The article's purpose was to report the medium to long term outcome of a homogeneous series of revision total knee revisions and to assess radiologically the incidence of sclerotic lines and relate them to the clinical outcome.Data was compiled from 46 revision total knee revisions with follow less than two years (46 patients with age range 47 to 88 years).Original implants are unknown.All revision implants were depuy implants.Cement manufacturer is not identified and patella resurfacing was not discussed.Article clarifies that femoral and tibial augments were utilized and the femoral stems were uncemented while other components were cemented.Depuy products: pfc sigma tc3 with stem, adaptor, and tibial and femoral augments adverse events: peroneal nerve lesions (no indication of intervention, no indication of impact, no further information provided) early infection (treated by debridement and antibiotics) chronic regional pain syndrome (no indication of intervention) severe mediolateral instability (treated by revision incorporating arthrodesis 6 years post op) symptomatic aseptic loosening of stem (treated by revision to a hinged prosthesis 8 years post op) radiologic detection of sclerotic lines in femoral and tibial side (no indication of intervention) stem subsidence (treated by revision) figure 1 reveals radiographic imaging of a (b)(6) male with asymptomatic progressive drift of femoral stem (no indication of intervention).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: corrected: h6 (closure codes and device codes).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE FEMORAL STEM
• Type of Device: UNK KNEE FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9648667
• MDR Text Key: 186844721
• Report Number: 1818910-2020-03654
• Device Sequence Number: 1
• Product Code: KXA
• 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: 01/21/2020

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 KNEE FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention