MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 9 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-908
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Swelling (2091); Weakness (2145); No Code Available (3191)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation: attorney.
Event or Problem Description
Right revision to address pain, instability, quad atrophy and quad weakness, effusion, and loosening of the tibial component at the implant/cement interface.There was wear with grooving and pitting to the underside of the rotating platform.There were cracks in the cement and a small crack in the medial condylar region, not complete, but consistent with probable stress fracture.Patella was noted to be overstuffed.
Additional Manufacturer Narrative
Udi: (b)(4).(b)(4) used to capture medical device removal and surgical intervention.
Event or Problem Description
(b)(4) and medical records alleges tibial loosening at the bone to cement interface.
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.Added: h6 (patient).H6 patient code: no code available (3191) was used to capture joint instability and atrophy.

• Brand Name: ATTUNE PS RP INSRT SZ 9 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7948938
• Report Number: 1818910-2018-71859
• Device Sequence Number: 1513743
• Product Code: NJL
• UDI-Device Identifier: 10603295053019
• UDI-Public: 10603295053019
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2018

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 Expiration Date: 04/30/2020
• Device Model Number: 1516-50-908
• Device Catalogue Number: 151650908
• Device Lot Number: 8118169
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2018
• Supplement Date Received by Manufacturer: 12/12/2019; 07/21/2020
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/19/2019; 07/28/2020
• 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: 66 YR