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

Catalog Number UNK KNEE FEMORAL ADAPTOR

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Edema (1820); Pain (1994); Skin Irritation (2076); Test Result (2695); No Code Available (3191)

Event Date 04/04/2012

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, "adverse local tissue response lesion of the knee associated with morse taper corrosion" written by william c.Mcmaster, md and jay patel, md published by the journal of arthroplasty vol.28 no.2 2013 accepted by publisher 4 april 2012 was reviewed.The article's purpose was to report on a case report of a (b)(6) year old man with a left tka who ten received a depuy lps in 2009 by revision to original implant (product not specified).Approximately 20 months post lps implantation he begin to experience swelling, loss of motion, and pain.He developed local knee skin rash with redness.Co levels were elevated at 30 mcg/l and pain progressed.Tests were negative for infection and no radiographic findings for cause of pain.Surgical exploration revealed black encrustations at the morse taper junction of the distal femoral component and well ingrown porous-coated intramedullary femoral stem extension and no signs of wear on the poly insert or bearing surfaces.Strong force required to disengage the taper junction where the implants presented with corrosion on both sides.Capsular debridement was performed but no significant signs of alval were present.A new distal femoral component was applied to the original ingrown femoral stem as a temporary fix and the hinged components were then reassembled.Patient healed without further complications.The article does not identify cement manufacturer, and no mention of patella resurfacing.Depuy products utilized: hinged lps with rotating platform.Adverse events: pain, swelling, skin reaction, joint loss of motion (attributed to pain), blood heavy metal increased, surgical intervention, implant corrosion at femoral adaptor/sleeve component junction.

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.Additional narrative: corrected: adverse event problem (device code).Product complaint # (b)(4).Investigation summary: the device associated with the reported event was not returned to the investigation site for evaluation.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.Device history lot: null.Device history batch: null.Device history review: null.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: 9364394
• MDR Text Key: 185085028
• Report Number: 1818910-2019-114992
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL ADAPTOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention