MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE CR RP INSRT SZ 5 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151630508
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	05/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The patient had a valgus knee.The surgeon used the prescribed technique using a measured sizer.A size 5 narrow femur, size 6 tibia tray and as sz 5 8mm poly were implanted.The patient was balanced in both extension and flexion with the 8mm poly.3 days later the patient was experiencing some pain; an x-ray was taken which showed that the insert had spun out.The surgeon did an mua and then subsequently decided to change the poly.On manipulation in theater it was quite obvious that the knee was very unstable.The 8mm poly was removed and a sz5 14mm poly insert was implanted.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.

• Brand Name: ATTUNE CR RP INSRT SZ 5 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8223209
• Report Number: 1818910-2019-80058
• Device Sequence Number: 263775
• Product Code: NJL
• UDI-Device Identifier: 10603295047773
• UDI-Public: 10603295047773
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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 Catalogue Number: 151630508
• Device Lot Number: 8067761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 02/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention