MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR RT SZ 8; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-01-208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/14/2021
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 pain.Doi: (b)(6) 2020.Dor: (b)(6) 2021, right knee.
Event or Problem Description
A.The der indicated loosening as "no" but a loosening interface has been marked/ticked.Can you confirm if there is loosening involved with this event? b.Please confirm if product/lot number of the explanted implants are available.If yes, please provide product details." which they replied: "just confirming that this was not a loosing issue.I reviewed the mdr and did not see where that was indicated a mark or ticked as you described? i also have submitted all lot numbers on the original der.Those must have been missed?".
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 FEM POR CR RT SZ 8
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12546309
• Report Number: 1818910-2021-21340
• Device Sequence Number: 20125963
• Product Code: MBH
• UDI-Device Identifier: 10603295041511
• UDI-Public: 10603295041511
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 09/14/2021

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: 1504-01-208
• Device Catalogue Number: 150401208
• Device Lot Number: 9426133
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/18/2021; 10/12/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/04/2021; 10/14/2021
• 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 CR RP INSRT SZ 3 5MM; ATTUNE FEM POR CR RT SZ 8; ATTUNE RP TIB BASE SZ 8 POR; ATTUNE CR RP INSRT SZ 3 5MM; ATTUNE FEM POR CR RT SZ 8; ATTUNE RP TIB BASE SZ 8 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR