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

Catalog Number	864180
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	06/27/2018
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
The primary surgery was performed to implant the implants to the patient¿s left knee joint (date of primary surgery was unknown).The patient complained the pain (about a year ago), so that the surgeon found the loosening of the knee implants.It was reported that the revision surgery was performed on (b)(6) 2018 due to the loosening.No further information was provided by the hospital.
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.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, will be filed as appropriate.

• Brand Name: PFC KEEL TIB TRAY CEM SZ2
• 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: 7706427
• Report Number: 1818910-2018-64881
• Device Sequence Number: 1405530
• Product Code: JWH
• UDI-Device Identifier: 10603295216421
• UDI-Public: 10603295216421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961685
• 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
• Report Date (Section B): 06/27/2018

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: 864180
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/20/2018
• 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: 80 YR
• Patient Weight: 50