MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL ADAPTOR

Catalog Number UNK KNEE FEMORAL ADAPTOR

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

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 01/01/2002

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, "impaction grafting and wire mesh for uncontained defects in revision knee arthroplasty" written by jess h.Lonner, md, paul a.Lotke, md, jane kim, ba, and charles nelson, md published by clinical orthopaedics and related research 2002 was reviewed.The article's purpose was to report on 17 revision total knee arthroplasties in 14 patients in whom large uncontained defects were treated with impaction allografting and molded wire mesh for containment.The original implants are not identified.The revision implants were all depuy products.The cement manufacturer is not identified and the article does not clarify if patella resurfacing was included.Table 1 provides patient by case number and it is noted adverse events were associated with patient #'s 7, 9 and 10.Also noted that patients #5 and 8 were noted in table for radiolucency in radiographic images which is suggestive of loosening but narrative description provides further details that the patients were not revised and clinically well.Each patient (7, 9 and 10) is captured individually in linked complaints.Depuy products utilized: press-fit condylar sigma total knee prosthesis including stems and extensions (clarified by article).This complaint captures case #7 (b)(6) year old (gender not provided) with r tka that experienced a long stem spiral periprosthetic femur fracture which developed 8 months postoperatively.The patient was treated with open reduction and internal fixation which healed without complications.

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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 ADAPTOR
• Type of Device: KNEE FEMORAL ADAPTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9416608
• MDR Text Key: 185243296
• Report Number: 1818910-2019-120724
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL ADAPTOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention