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

Model Number	1517-10-508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Joint Laxity (4526)
Date of Event	07/20/2021
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
Revision left total knee replacement.Removal of attune revision implants, (tibial sleeve was not removed), due to stiffness, instability.There was no extended surgical time.Surgeon stated the femoral implant was oversized.No deficiency with the product.
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 CRS RP INSRT SZ 5 8MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12277388
• Report Number: 1818910-2021-17050
• Device Sequence Number: 3164498
• Product Code: NJL
• UDI-Device Identifier: 10603295055914
• UDI-Public: 10603295055914
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1517-10-508
• Device Catalogue Number: 151710508
• Device Lot Number: 8745616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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 CRS FEMORAL LT SZ 5 CEM.; ATTUNE CRS RP INSRT SZ 5 8MM.; ATTUNE DIST FEM AUG SZ 5 4MM.; ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE POS FEM AUG SZ 5 4MM.; ATTUNE POS FEM AUG SZ 5 8MM.; ATUN PRESSFIT STR STEM14X110MM.; ATUN TIB SLV M/L 37MM FULL POR.; ATUNE PRESSFIT STR STEM14X60MM.; ATUNE REV RP TIB BASE SZ 5 CEM.; CEMENT MFG AND PRODUCT NAME UNKNOWN.; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE CRS RP INSRT SZ 5 8MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 5 4MM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; CEMENT MFG AND PRODUCT NAME UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR