MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 3 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640307
Medical Device Problem Codes	Disassembly (1168); Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	12/01/2017
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 primary surgery on (b)(6) 2017.On (b)(6) 2017, the surgeon found that the insert was dissociated under x-ray when the patient visited to the hospital.The revision surgery was performed on (b)(6) 2018 by replacing the insert.After the revision surgery, the surgeon found that the tab in front of the insert was broken.No further information was provided by the hospital.
Additional Manufacturer Narrative
(b)(4) investigation summary examination of the returned device confirms the reported event.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.Device history lot: product code 151640307, lot number 632244 device history review dhr reviewed, no nonconformances were noted.Ri/coc review no anomalies were noted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FB INSRT SZ 3 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7475427
• Report Number: 1818910-2018-58613
• Device Sequence Number: 2052728
• Product Code: JWH
• UDI-Device Identifier: 10603295049661
• UDI-Public: 10603295049661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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 Catalogue Number: 151640307
• Device Lot Number: 632244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 05/25/2018
• 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: 81 YR