MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 7 22MM; KNEE TIBIAL INSERT

Model Number	1517-10-722
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)
Date of Event	03/26/2020
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
Primary surgery: (b)(6) 2019.Removal of attune revision, patient required all implants removed due to instability and infection (no collateral ligaments) from revision.There was a poly exchange due to instability.
Event or Problem Description
Additional information received on (b)(6) 2020 stating that the infection has not been confirmed and is not the cause of instability.It was caused by a knee dislocation sustained when the patient was kicked in the knee while in prison.No allegation of fault stated by the surgeon against the products.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CRS RP INSRT SZ 7 22MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9934294
• Report Number: 1818910-2020-10372
• Device Sequence Number: 10951248
• Product Code: NJL
• UDI-Device Identifier: 10603295056201
• UDI-Public: 10603295056201
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2020

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 Model Number: 1517-10-722
• Device Catalogue Number: 151710722
• Device Lot Number: 8983851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 04/07/2020; 05/12/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/16/2020; 05/13/2020
• 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; ATTUNE POS FEM AUG SZ 5 8MM; ATTUNE POS FEM AUG SZ 5 8MM; ATTUNE TIB SLV CEM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM10X60MM; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; ATTUNE CRS FEMORAL LT SZ 5 CEM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE DIST FEM AUG SZ 5 4MM; ATTUNE POS FEM AUG SZ 5 8MM; ATTUNE POS FEM AUG SZ 5 8MM; ATTUNE TIB SLV CEM; ATUN FEM SLV M/L 30MM HALF POR; ATUNE PRESSFIT STR STEM10X60MM; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 4 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR