MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MED RT 71X66; LPS AND S-ROM : KNEE FEMORAL

Model Number 62-3401R

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

Patient Problems Abscess (1690); Joint Dislocation (2374); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/30/2010

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

Clinical adverse event received for vascular compromise with subsequent compartment syndrome and grafting : infection - deep.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2004, date of event (onset): (b)(6) 2010, (right knee).Treatment: revised on (b)(6) 2011, all products explanted.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2004, the patient underwent a bilateral knee arthroplasty due to arthritis.Depuy products were implanted in both knees.There were no indicated intra-operative complications.On (b)(6) 2011, the patient underwent a right knee revision to address infection, compartment syndrome, dislocation, instability, and abscess.All components were noted to be removed and replaced with articulating antibiotic spacer.Unknown manufacturer products were implanted during the revision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SROM NRHFEM W/PIN MED RT 71X66
• Type of Device: LPS AND S-ROM : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11334406
• MDR Text Key: 232084727
• Report Number: 1818910-2021-03100
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295179474
• UDI-Public: 10603295179474
• Combination Product (y/n): N
• PMA/PMN Number: K896048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 62-3401R
• Device Catalogue Number: 623401R
• Device Lot Number: C66FJ4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS UNIV TIB HIN INS MED 21MM; MBT REVISION CEM TIB TRAY SZ 5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SROM NRHFEM W/PIN MED RT 71X66; TAPER CEM STEM 13X90; UNIVERSAL FEM SLV FUL POR 46MM; LPS UNIV TIB HIN INS MED 21MM; MBT REVISION CEM TIB TRAY SZ 5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SROM NRHFEM W/PIN MED RT 71X66; TAPER CEM STEM 13X90; UNIVERSAL FEM SLV FUL POR 46MM
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 109