MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Joint Disorder (2373); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Date of Event	10/29/2018
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.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).
Event or Problem Description
Patient was revised to address loosening of the tibial component at bone to cement and cement to implant interface.Cement manufacturer was from competitor.The tibial component, femoral component and the patella were removed.There was no bone cement present to the tibial interface underside.There was also slim to no bone cement in the keeled portion of the tray.Legal claim: it was also alleged medical device removal, pain, discomfort, joint instability and walking difficulty.Doi: (b)(6) 2017.Dor: (b)(6) 2018; left 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H6 patient code: no code available (3191) used to capture the medical device removal.

• Brand Name: ATTUNE PS FEM LT SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 9458535
• Report Number: 1818910-2019-122736
• Device Sequence Number: 14225867
• Product Code: JWH
• UDI-Device Identifier: 10603295041665
• UDI-Public: 10603295041665
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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 Model Number: 1504-10-109
• Device Catalogue Number: 150410109
• Device Lot Number: 8410905
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 09/04/2020
• 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: 50 YR