MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PFC KEEL TIB TRAY CEM SZ5; KNEE TIBIAL TRAY

Catalog Number	864183
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Codes	Granuloma (1876); Pain (1994)
Date of Event	11/03/2017
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
Surgeon: dr (b)(6).Procedure: revision tkr.Patient underwent primary total knee replacement approximately 10 years ago where pfc cr cemented components were utilised ((b)(6), ((b)(6) hospital).Patient has presented for follow up and a painful knee.X rays show a large granuloma in the proximal tibia, just below the tibial tray.A decision was made to revise the joint.Joint was revised on (b)(6) 2017 (dr (b)(6)).On opening the joint the tibial tray was found to be loose.The proximal tibia had an extensive granuloma.The femoral component was relatively well fixed.Femoral and tibial components were removed and the patella component left in situ.A stemmed tibial and femoral pfc tc3 was implanted.Knee appeared stable.Male patient initials (b)(6), aged (b)(6), dob (b)(6).X-rays available.Unknown jrn: pfc sigma cr cemented femur size 5 right = discarded.Unknown jrn: pfc sigma cuciform keel tray size 5 = discarded.Unknown jrn: pfc sigma cr bearing size 5 x? = discarded.Unknown jrn: pfc patella = still implanted.
Additional Manufacturer Narrative
Pc-(b)(4).No device associated with this report was received for examination.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: PFC KEEL TIB TRAY CEM SZ5
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7122096
• Report Number: 1818910-2017-51824
• Device Sequence Number: 13805544
• Product Code: JWH
• UDI-Device Identifier: 10603295216452
• UDI-Public: 10603295216452
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K961685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2017

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: 864183
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 12/28/2017; 05/11/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 12/29/2017; 05/14/2018
• 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: 75 YR