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

Model Number	1516-30-905
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Loss of Range of Motion (2032)
Date of Event	05/13/2021
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 underwent primary tkr on (b)(6) 2021 where an attune uncemented tibial component and an attune uncemented femoral component was utilised.Surgeon mentioned that he was required to undertake manipulation under anaesthesia (mua) patient consequence description/ a clinical outcome experienced by the patient: limited rom, stiffness.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 CR RP 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: 11884076
• Report Number: 1818910-2021-11185
• Device Sequence Number: 3685643
• Product Code: NJL
• UDI-Device Identifier: 10603295048220
• UDI-Public: 10603295048220
• 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: 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): 05/13/2021

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: 1516-30-905
• Device Catalogue Number: 151630905
• Device Lot Number: 9514712
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/10/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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 FEM POR CR LT SZ 9; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE RP TIB BASE SZ 10 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR