MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE PS FB INSRT SZ 4 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-410
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	04/05/2019
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
The patient was revised to address loosening of the tibial component at the cement to implant interface.It was also reported that the tibia was found to be grossly loose with no cement adherence.Pitting of the poly insert was also noted.The patient was revised to a full sigma knee revision.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).Is used to capture the medical device removal.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H10 additional narrative: corrected: g1, g2.

• Brand Name: ATTUNE PS FB INSRT SZ 4 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8557624
• Report Number: 1818910-2019-91803
• Device Sequence Number: 2443453
• Product Code: JWH
• UDI-Device Identifier: 10603295049821
• UDI-Public: 10603295049821
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/05/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 1516-40-410
• Device Catalogue Number: 151640410
• Device Lot Number: 579137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 12/11/2019; 09/24/2020
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/29/2019; 01/07/2020; 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR