MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-20-605

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

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032)

Event Date 07/14/2021

Event Type  Injury  

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 Description

Patient was revised due to limited rom.Surgeon was able to clear out scar tissue and do a lateral release of patella tendon which in combination gave the patient high rom.Insert was removed.Doi: (b)(6) 2014 dor: (b)(6) 2021 left knee.

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 FB INSRT SZ 6 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12275480
• MDR Text Key: 264999627
• Report Number: 1818910-2021-17009
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295045762
• UDI-Public: 10603295045762
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 1516-20-605
• Device Catalogue Number: 151620605
• Device Lot Number: 7799908
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FB INSRT SZ 6 5MM.; ATTUNE CR FEM LT SZ 6 NAR CEM.; ATTUNE FB TIB BASE SZ 5 CEM.; ATTUNE MEDIAL DOME PAT 35MM.; DEPUY CMW 2 20G.; DEPUY CMW 2 20G.; ATTUNE CR FB INSRT SZ 6 5MM; ATTUNE CR FEM LT SZ 6 NAR CEM; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 35MM; DEPUY CMW 2 20G; DEPUY CMW 2 20G
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR