MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 2 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-00-002
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2021
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
Patient was revised due to aseptic tibial loosening at the cement to implant interface.Unknown cement was used.Surgeon explanted components revising with crs.Doi: (b)(6) 2015 dor: (b)(6) 2021 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.Device history lot: product code 150600002, work order (b)(4) was manufactured on 04-dec-2013.(b)(4) parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports (mrr) associated with this lot.Non-conformance: there were no non-conformances associated with this lot.

• Brand Name: ATTUNE FB TIB BASE SZ 2 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12359551
• Report Number: 1818910-2021-18500
• Device Sequence Number: 3936744
• Product Code: OIY
• UDI-Device Identifier: 10603295042365
• UDI-Public: 10603295042365
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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 Model Number: 1506-00-002
• Device Catalogue Number: 150600002
• Device Lot Number: 7813886
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/15/2021
• 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 FB TIB BASE SZ 2 CEM; ATTUNE PS FB INSRT SZ 3 5MM; ATTUNE PS FEM RT SZ 3 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); ATTUNE FB TIB BASE SZ 2 CEM; ATTUNE PS FB INSRT SZ 3 5MM; ATTUNE PS FEM RT SZ 3 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR