MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV LPS INSRT XXSM 12MM; KNEE TIBIAL INSERT

Model Number 1517-60-112

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/18/2021

Event Type  Injury  

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 Description

It was reported that the patient had a dfr done on (b)(6) 2020.She ruptured her quadriceps tendon in (b)(6) 2020 and now had an infection.The insert, poly button and hinge pin were removed.The joint was washed and scrubbed then a new insert, poly button and hinge pin were implanted.No surgical delay noted.Doi: (b)(6) 2020, dor: (b)(6) 2021, right knee.

Event Description

Additional information was received stating that there were no implants revised at the time of the extensor mechanism repair.The patella has an implant on it.The implant is not a depuy implant and it was not revised.

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.Removed clinical symptoms code tendon injury.

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 REV LPS INSRT XXSM 12MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11253188
• MDR Text Key: 229439101
• Report Number: 1818910-2021-02120
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295491064
• UDI-Public: 10603295491064
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1517-60-112
• Device Catalogue Number: 151760112
• Device Lot Number: J66F74
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE REV LPS INSRT XXSM 12MM; COMPETITOR PATELLA; LPS DIST FEM POLY BUMPER XXSM; LPS XX-SM HINGE PIN; ATTUNE REV LPS INSRT XXSM 12MM; LPS DIST FEM POLY BUMPER XXSM; LPS XX-SM HINGE PIN
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR