MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 16MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2019
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
It was reported that the patient had a rt tka done a number of years ago with a competitor.The patient fell and then had a femur fracture.Then the patient developed a knee infection.The surgeon removed the competitor knee and hardware and put in a spacer.It was then on (b)(6) 2019 that the surgeon used depuy to revise the spacer with attune revision and the final result was very good.However, over the past month, this patient had been complaining of an unstable feeling when bending his knee in flexion.The surgeon saw the patient in the clinic and said that the patients flexion gap had increased over time and the patient still had flexion stability.The surgeon wanted to do a poly exchange and a take out of the stabilized rp insert and put in a crs insert along with increasing it's thickness.He also was ready to revise the entire femur if necessary.The surgeon opened the patient up and removed the poly.Trialing was done with a 20 crs poly.The knee was still able to get extension and flexion instability was solved by going up from a 16mm ps rp to a 20 mm crs rp.The surgeon then closed the knee.Doi: (b)(6) 2019; dor: (b)(6) 2019; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS RP INSRT SZ 8 16MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9249576
• Report Number: 1818910-2019-112779
• Device Sequence Number: 2104980
• Product Code: NJL
• UDI-Device Identifier: 10603295052913
• UDI-Public: 10603295052913
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 151650816
• Device Lot Number: 8767828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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: 56 YR