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

Catalog Number UNK KNEE FEMORAL SLEEVE

Device Problems Fracture (1260); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 01/01/2016

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, "mechanical failure of revision knee prosthesis at both femoral and tibial modular metaphyseal stem junctions" written by ian g woodgate, john rooney, johnathan s.Mulford, and r.Mark gillies published by journal of orthopaedic case reports 2016 jan-mar: 6 (1): page 40-43 was reviewed.The article's purpose is to discuss a case of a (b)(6) male who received a cemented srom prosthesis after his original tka required revision due to infection.Original implants are unknown.Components implanted during the revision were a cemented srom modular tibial plate, tibial sleeve, uncemented stem extension, femoral cemented noiles rotating hinge component with femoral sleeve and uncemented femoral extention.Cement manufacturer is unknown and patella resurfacing was not performed.Approximately 3 years later, patient experienced a fall and presented with pain, edema and requirement of walking aide due to decreased functional ability.Radiographs reveal broken tibial wire, osteolysis and pedestal formation around both the femoral and distal tibial stem extensions.The "prosthesis was bent at the proximal tibial sleeve and stem junction." the patient was referred for weight loss in order to perform revision knee procedure.After patient lost 120 kgs, the 2nd revision surgery was performed and intraoperative findings included marked metallosis, loosening of the femoral and tibial components at cement-bone interface, fractures on femoral tibial components at the modular metaphyseal sleeve-stem junction.Procedure included debridement, reconstruction with anatomic specific structural and morcellised impaction allograft and then replacement with another srom modular revision stemmed implant cemented into place.Depuy products utilized: srom hinged prosthesis adverse events: fall pain edema revision surgery metallosis requiring debridement femoral component loosening at cement-bone interface tibial component loosening at cement-bone interface tibial prosthesis fracture at sleeve-stem taper junction femoral prosthesis fracture at sleeve-stem taper junction.

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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN KNEE FEMORAL SLEEVE
• Type of Device: KNEE FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9597263
• MDR Text Key: 178347876
• Report Number: 1818910-2020-02044
• 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: 01/06/2020

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 SLEEVE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention