MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TC3 RP TIBIAL INSERT S5,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	962362
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Der states that patient's knee was revised because of knee pain, due to possibly cement disease.The patient insisted that it be revised, even though all of the components appeared to be well fixed.All of the components were well fixed.Only the femoral component, patella component, and tibial insert were replaced during the revision procedure.There did appear to be some delamination of the patella component upon examination.Cement manufacturer unknown.Doi: unknown dor: (b)(6) 2018 right knee.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > examination of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TC3 RP TIBIAL INSERT S5,12.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7435675
• Report Number: 1818910-2018-57485
• Device Sequence Number: 11091472
• Product Code: JDI
• UDI-Device Identifier: 10603295242499
• UDI-Public: 10603295242499
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K802627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2018

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: 962362
• Device Lot Number: BF022350271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 05/16/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 04/17/2018; 05/17/2018
• 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: 47 YR