MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FB INSRT SZ 6 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-614
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	10/12/2018
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.(b)(4).
Event or Problem Description
Patient was revised to address loosening of the tibial component at cement to implant interface.
Additional Manufacturer Narrative
(b)(4).Investigation summary: 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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  udi: (b)(4).No code available was used to capture medical device removal.
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.Patient code: no code available (3191) is used to capture prolonged surgery and insufficient information.

• Brand Name: ATTUNE PS FB INSRT SZ 6 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8027992
• Report Number: 1818910-2018-74161
• Device Sequence Number: 19207165
• Product Code: JWH
• UDI-Device Identifier: 10603295050124
• UDI-Public: 10603295050124
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 1516-40-614
• Device Catalogue Number: 151640614
• Device Lot Number: 408425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 01/05/2020; 10/15/2020
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 12/10/2018; 01/17/2020; 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 38MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR