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 Adhesion(s) (1695); Unspecified Tissue Injury (4559)

Event Date 09/28/2022

Event Type  Injury  

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.

Event Description

Revision completed due to significant scarring and had poor quad function.Patient has had multiple surgeries.Patient had a tc3 rp revision placed in (b)(6) 2018, which many items were removed and converted to distal femoral replacement on (b)(6) 2021(femoral sleeve and stem were retained).Femoral side was revised and joint line was elevated to try to adjust patella position and improve quad function.Femoral side was uncemented.No patient harm was occurred.No surgical delay was reported.No additional information was received.Doi: (b)(6) 2018.Dor: (b)(6) 2022.Affected side: right knee.

Event Description

Additional information received: 1.Was there any indication the femoral component was misaligned? 2.It was indicated that der was submitted on the 2021 surgery.Can you please provide the complaint number? 3.Please confirm if the patella was implanted or native.Answers: 1.No 2.No 3.A 960100 lot 9034143 was implanted in the revision in 3/2021.It was left in place at this last revision.

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 REV LPS INSRT XXSM 12MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15587649
• MDR Text Key: 301578009
• Report Number: 1818910-2022-20210
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295491064
• UDI-Public: 10603295491064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2022

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
• Device Operator: Health Professional
• Device Model Number: 1517-60-112
• Device Catalogue Number: 151760112
• Device Lot Number: J89G31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 10/14/2022; 10/21/2022
• Supplement Dates FDA Received: 10/18/2022; 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LPS DISTAL FEM COMP XXSM RT; LPS FEM TO SLEEVE ADAPTER +0; PFC*SIGMA/OV DOME PAT 3 PEG,32; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 75X14MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 100 KG