MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR FB INSRT SZ 7 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151620707
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330)
Date of Event	10/26/2014
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
Medical records received.After review of the medical records for mdr reportability, the patient underwent a poly exchange for infection, pain, and discomfort on (b)(6) 2014.The patient had a previous realignment and arthrotomy on (b)(6) 2014 for flexion injury, instability, and partial quad rupture with no revision of products.(b)(6) 2014; (b)(6) 2014 (right knee).
Additional Manufacturer Narrative
The insert was reported in error.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 7 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7221267
• Report Number: 1818910-2018-52133
• Device Sequence Number: 2300607
• Product Code: JWH
• UDI-Device Identifier: 10603295045908
• UDI-Public: 10603295045908
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 151620707
• Device Lot Number: 460385
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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: 42 YR