MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE REV LPS INSRT XSM 12MM; KNEE TIBIAL INSERT

Model Number 1517-60-212

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

Patient Problem Pain (1994)

Event Date 09/15/2022

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

It was reported that implants were inserted on 2 different dates as a partial revision was performed on the second date, (b)(6) 2021.A der was submitted at that time.First 3 items listed were left from (b)(6) 2020 procedure, the rest were placed in may 21.Patient complained of tibial pain.Xrays appeared to have lucencies on the tibial side so a tibial side revision was planned.Insert and femoral component were removed for exposure, then tibial tray and stem were removed, but the tibial sleeve was found to be well fixed.The surgeon wanted to shorten the adapter on the femoral sleeve and when trying to remove the adapter the femoral sleeve and stem were extracted.At this point, a tibial and femoral revision were perfumed uneventfully.There was no patient harm.Doi: (b)(6) 2020.Dor: (b)(6) 2022.Affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this complaint was not returned.Photo evidence of x-rays provided was reviewed and no product issue was identified.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code 151760212 /lot code j89r93 combination.Based on the inability to find any nc¿s against the provided product code /lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.H10 additional narrative:.

• Brand Name: ATTUNE REV LPS INSRT XSM 12MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15526008
• MDR Text Key: 300997259
• Report Number: 1818910-2022-19290
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295490968
• UDI-Public: 10603295490968
• 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
• Report Date: 10/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1517-60-212
• Device Catalogue Number: 151760212
• Device Lot Number: J89R93
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• 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: ATTUNE REV LPS INSRT XSM 12MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 2 CEM; CONTROL CABLE W/CABLE SLEEVE; LPS DISTAL FEM COMP XSM RT; LPS FEM TO SLEEVE ADAPTER +5; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X14MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 77 KG