MAUDE Adverse Event Report: DEPUY RAYNHAM ¿ 1219655 ATTUNE CR FB INSRT SZ 5 10MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	151620510
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/13/2017
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.
Event or Problem Description
The der indicates that surgeon states the patient dislocated her knee posteriorly post-operatively while still in the hospital.He did a reduction under anesthesia and felt the knee was stable.After the patient left the hospital she dislocated posteriorly again while getting off the toilet.Surgeon brought the patient to the or for a revision.It was determined intra-op that the medial side of the knee joint opened up 1cm.Primary inserts were trialed and the decision was made to convert to a tc3 rp knee for stability.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.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 5 10MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6855596
• Report Number: 1818910-2017-24442
• Device Sequence Number: 16429461
• Product Code: JWH
• UDI-Device Identifier: 10603295045687
• UDI-Public: 10603295045687
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/13/2017

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: 151620510
• Device Lot Number: C40227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: 59 YR