MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC KEEL TIB TRAY CEM SZ2.5; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Catalog Number	864177
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/24/2018
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.Concomitant medical products: tibial insert.
Event or Problem Description
Patient was revised to address aseptic loosening of the tibia at the cement to implant interface.Competitor cement was used.No falls or trauma.Replaced with stemmed/sleeved mbt tray.Doi: (b)(6) 2003; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the implant associated with this report was not returned.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: PFC KEEL TIB TRAY CEM SZ2.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7801290
• Report Number: 1818910-2018-67269
• Device Sequence Number: 1862131
• Product Code: JWH
• UDI-Device Identifier: 10603295216391
• UDI-Public: 10603295216391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K961685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 864177
• Device Lot Number: 312949
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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
• Patient Weight: 70