MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 5 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-514
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 patient was revised to address dissociated tibial insert.Dissociated tibial insert twice: once after the primary and again after the first revision/insert exchange.Doi: (b)(6) 2017.Doi: (b)(6) 2018 ( insert and tray ).Dor: (b)(6) 2018.Right knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no product associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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.
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. h10 additional narrative: udi: (b)(4).Added: a2 (birth date), d4 (expiration), h6 (patient).No code available was added to capture medical device removal.
Event or Problem Description
Medical records alleges tibial loosening at the cement to implant interface.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = update 21-jan-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot =device history records review for product no.151620514 lot no.7796606 description attune cr fb insrt sz 5 14mm.25 parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.Coc review certificate of conformance 6960817 reviewed for product code 151620600, work order (b)(4) and met specification.

• Brand Name: ATTUNE CR FB INSRT SZ 5 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7649826
• Report Number: 1818910-2018-63464
• Device Sequence Number: 184341
• Product Code: JWH
• UDI-Device Identifier: 10603295045700
• UDI-Public: 10603295045700
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2018

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 Model Number: 1516-20-514
• Device Catalogue Number: 151620514
• Device Lot Number: 7796606
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 01/20/2020; 01/21/2021
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/02/2018; 01/24/2020; 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR'S BONE CEMENT; COMPETITOR'S BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR