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

Model Number	1516-30-508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	08/10/2020
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.
Event or Problem Description
The patient was revised to address loosening of the tibial component at the cement to implant interface.Unknown cement was used.It was also reported that the patient had bilateral knee on (b)(6) 2016 and came in the office complaining of pain and instability.After xrays were taken, they could see that the tibia on her right side had collapsed and fallen into callus.The implant was easily removed and replaces with a revision tibial tray.Patient appeared to be stable after revision was completed.Doi: (b)(6) 2016, dor: (b)(6) 2020, right knee.
Event or Problem Description
Additional information received stated that the pin got stuck in the proximal tibia cutting guide.Surgery was extended by about 1 minute while removing the stuck pin.
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.

• 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: 10437144
• Report Number: 1818910-2020-18534
• Device Sequence Number: 16864222
• Product Code: NJL
• UDI-Device Identifier: 10603295047773
• UDI-Public: 10603295047773
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 1516-30-508
• Device Catalogue Number: 151630508
• Device Lot Number: 8023637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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 CR RP INSRT SZ 5 8 MM; ATTUNE RP TIB BASE SZ 5 CEM; ATTUNE CR RP INSRT SZ 5 8 MM; ATTUNE RP TIB BASE SZ 5 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR