MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	940023
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision tkr, (b)(6) private hospital (b)(6) 2018.Patient underwent primary tkr on (b)(6) 2011.Patient has been doing well until approximately 9 months ago where the knee has become both progressively painful as well as progressively stiff.Patient was achieving approximately 45 degrees of flexion 6 months ago and at time of surgery was only achieving approximately 30 degrees flexion.On opening the knee, both the tibial and femoral implants appeared well fixed.Scar tissue was present in the inter condylar notch.The knee was removed and a pfc tc3 implanted.Patient was achieving approximately 110 degrees on the table.Doi: (b)(6) 2011;dor: (b)(6) 2018; unknown affected side.
Additional 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.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: SIG C/R POROCOAT FEM RT SZ 3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7247139
• Report Number: 1818910-2018-52906
• Device Sequence Number: 19136526
• Product Code: JWH
• UDI-Device Identifier: 10603295223474
• UDI-Public: 10603295223474
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K062654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 940023
• Device Lot Number: E64LS1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR