MAUDE Adverse Event Report: DEPUY RAYNHAM ¿ 1219655 ATTUNE CR FB INSRT SZ 7 10MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	151620710
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/10/2017
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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
Der states that the patient chief complaint is pain.The surgeon went in and removed the tibial component and replaced it with an attune revision fixed bearing tibial tray and insert.Surgeon went up on the poly insert one thickness.He also asked that i send the explanted components to (b)(6) to be studied.The femur and patella were well fixed and not removed.
Additional Manufacturer Narrative
No device associated with this report was received for examination.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.Depuy considers the investigation closed at this time.Should the 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: ATTUNE CR FB INSRT SZ 7 10MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7010396
• Report Number: 1818910-2017-28319
• Device Sequence Number: 10886973
• Product Code: JWH
• UDI-Device Identifier: 10603295045922
• UDI-Public: 10603295045922
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 151620710
• Device Lot Number: 213145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR