MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV DIS POR 40MM; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY

Model Number 1294-53-235

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

Patient Problems Edema (1820); Erythema (1840); Pain (1994); Injury (2348); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2020

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.

Event Description

Suspicion of contact allergy to the 3rd right knee prosthesis.Knee prosthesis put in place because of bad consolidation and increasing age.Left prosthesis (it is not a product from depuy synthes): put in place 8 years ago, well tolerated (except few pains).Right prosthesis: first prosthesis (it is not a product from depuy synthes): put in place in 2014.Pains with suspicion of loosening for no apparent reason.Second prosthesis (it is not a product from depuy synthes): put in place in 2016 (replacement.Pains with suspicion of infection.Third prosthesis: put in place in (b)(6) 2019 (replacement).More pains, erythema / edema and knee vesicles.The patient has been treated with several antibiotics without success.No treatment with dermocorticoid.Procedure performed in (b)(6) 2019: replacement of a three compartment knee prosthesis without bone reconstruction.The postoperative follow-up was marked by section of the artery and the popliteal vein during the surgical procedure, taken care of by vascular surgeons with anastomosis resection.The general healing has been favorable.Rehabilitation program: walking in full support, stand up authorized.Procedure performed in (b)(6) 2019: replacement of a three compartment knee prosthesis without bone reconstruction.The postoperative follow-up was marked by section of the artery and the popliteal vein during the surgical procedure, taken care of by vascular surgeons with anastomosis resection.The general healing has been favorable.Rehabilitation program: walking in full support, stand up authorized.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified 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.Corrected: h6 patient codes (edema, pain and erythema will be retracted).Removed: (3191) device revision or replacement and corrected it with (3191) surgery.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received states that the implantation date of the right knee was (b)(6) 2019.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found one other complaint, (b)(4)., which is associated with the same patient.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: UNIVERSAL FEM SLV DIS POR 40MM
• Type of Device: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10283391
• MDR Text Key: 200779701
• Report Number: 1818910-2020-16034
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295026327
• UDI-Public: 10603295026327
• Combination Product (y/n): N
• PMA/PMN Number: K063633
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1294-53-235
• Device Catalogue Number: 129453235
• Device Lot Number: HY9576
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS UNIV TIB HIN INS MED 18MM; MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 37MM; P.F.C.* FLUT TIB ROD 115X16MM; P.F.C.* FLUT TIB ROD 75X18MM; SROM NRHFEM W/PIN MED RT 71X66; UNIVERSAL FEM SLV DIS POR 40MM
• Patient Outcome(s): Required Intervention