MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 9 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-905
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Muscular Rigidity (1968)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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
On (b)(6) 2017, the patient underwent a left knee attune arthroplasty.The patella was resurfaced, and cement manufacturer was unknown.There were no complications noted.Unknown part/lot on (b)(6) 2019, the patient presented with stiffness and recurrent hemathrosis.The patient underwent a revision and the tibial component was found to be loose.The cement was debonded from the tibial tray.Tibial tray was removed without difficulty and bone stock was in good condition.The femoral component, and patella was noted to be well fixed and in good condition.Neither of them were revised.An attune revision tibial tray was placed as revision with depuy cement used.Doi: (b)(6) 2017; dor: (b)(6) 2019; 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 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 9 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10900395
• Report Number: 1818910-2020-25478
• Device Sequence Number: 14075950
• Product Code: JWH
• UDI-Device Identifier: 10603295050483
• UDI-Public: 10603295050483
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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 Expiration Date: 07/31/2021
• Device Model Number: 1516-40-905
• Device Catalogue Number: 151640905
• Device Lot Number: C67461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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 8 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 9 CEM; COMPETITOR (STRYKER) BONE CEMENT; COMPETITOR (STRYKER) BONE CEMENT; ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 9 CEM; COMPETITOR (STRYKER) BONE CEMENT; COMPETITOR (STRYKER) BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR