MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CEMENTED STEM 14X50MM; ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE STEMS

Model Number 1512-14-050

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

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 the surgeon was impacting the revision tibial components in the revision tibia construct sat up several mm from where the trial sat when cementing.He had to remove tibia clear out all the cement that he just mixed for implants because it hardened.We had to open new tibial components for patient which caused a 35-40 min delay in the case.Doi: (b)(6) 2021, doe: (b)(6) 2021, right 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: a manufacturing record evaluation was performed for the finished device 151214050, lot d21083338 number, and no non-conformances / manufacturing irregularities were identified.(b)(4).

• Brand Name: ATTUNE CEMENTED STEM 14X50MM
• Type of Device: ATTUNE STEMMABLE TIBIA IMPLANTS : KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12954978
• MDR Text Key: 282202199
• Report Number: 1818910-2021-27422
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295475163
• UDI-Public: 10603295475163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160700
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1512-14-050
• Device Catalogue Number: 151214050
• Device Lot Number: D21083338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ATTUNE CEMENTED STEM 14X50MM; ATUN TIB SLV M/L 29MM HALF POR; ATUNE REV RP TIB BASE SZ 4 CEM