MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LEAVE ACTIVE PFC CVD 15MM SZ5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	864160
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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 of pfc tkjr; (b)(6) hospital, "(b)(6)" 2018.Primary implant year 2005.Revision of (r) tkjr due to osteolysis surrounding the joint.¿everywhere¿ (as per surgeon).Jnj representatives - (b)(6) were present for the case.All pfc implants removed and attune revision performed.Male patient id: (b)(6).Impacted product: unknown jrn: pfc cruciform keel tray size 5 fb / lot # unknown, unknown jrn: pfc cr femur ? size / lot # unknown, unknown jrn: pfc cr fb insert size 5 / lot # unknown.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device revealed damage, scratching and pitting.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: LEAVE ACTIVE PFC CVD 15MM SZ5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7637378
• Report Number: 1818910-2018-63155
• Device Sequence Number: 19381796
• Product Code: JWH
• UDI-Device Identifier: 10603295063582
• UDI-Public: 10603295063582
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2018

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: 864160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 10/03/2018; 11/27/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 10/04/2018; 12/07/2018
• 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: 84 YR