MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FB INSRT SZ 10 5MM; KNEE TIBIAL INSERT

Catalog Number	151621005
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/15/2017
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
Patient was revised to address rapid increase in pain and loosening of the tibial component at cement to implant interface.Cement manufacturer is from depuy.It was also reported that x-rays shows a large anterior medial defect all the way through the bone.Ap x-ray shows medial collapse of tibia.Surgeon felt this was a case of aseptic loosening of tibia with additional factors of obesity and possible fungal infection.The later wasn¿t confirmed by pathology at this time.The surgeon was concerned with the amount of scratching, pitting and wear that they poly components.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the received devices were evaluated by depuy commercialized product development.Review confirms the reported event.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.No product contribution to the reported event was identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 10 5MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7107636
• Report Number: 1818910-2017-51261
• Device Sequence Number: 16411365
• Product Code: JWH
• UDI-Device Identifier: 10603295046240
• UDI-Public: 10603295046240
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: 151621005
• Device Lot Number: 447901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/05/2018
• 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: 69 YR
• Patient Weight: 144