MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 26MM; KNEE TIBIAL INSERT

Model Number	1517-10-526
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The patient was revised to address rotation of the tibial insert.The surgeon removed the attune femoral components and revised the knee to an s-rom hinge knee.The patient had a previous revision of the tibial insert due to subluxation and the insert rotating 90 degrees.Doi: (b)(6) 2020.Dor: (b)(6) 2020; left knee.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received stated that the patient could not fully flex the knee.The post rotated 90 degrees and did not come off the insert.
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:  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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE CRS RP INSRT SZ 5 26MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10154992
• Report Number: 1818910-2020-13792
• Device Sequence Number: 16749218
• Product Code: NJL
• UDI-Device Identifier: 10603295056003
• UDI-Public: 10603295056003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1517-10-526
• Device Catalogue Number: 151710526
• Device Lot Number: 9040930
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020; 06/22/2020; 07/15/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 06/24/2020; 07/01/2020; 07/16/2020
• 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 DIST FEM AUG SZ 5 4MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN PRESSFIT STR STEM16X110MM; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN PRESSFIT STR STEM16X110MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 130