MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 6 10MM; KNEE TIBIAL INSERT

Model Number	1517-10-610
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
This (b)(4) is related to (b)(4) and (b)(4).(b)(4) reports that spin out occurred after the primary surgery.(b)(4) reports that the reoperation was performed without wound opening.This pc reports that spin out occurred again after the reoperation.It was reported that on (b)(6) 2022, spin out was confirmed by x rays.The surgeon planned to perform manual reduction under non-anesthesia.The surgeon asked the sales rep if he should perform the open reduction and replace the insert, although he did not know the open reduction would be successful.If the insert is to be replaced, a revision surgery was scheduled on (b)(6) 2022.On (b)(6) 2022, manual reduction was performed, and it was completed successfully without any surgical delay.The patient was placed in a cast in the extended position, and the surgeon will follow up the patient.No further information is available.
Additional 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 CRS RP INSRT SZ 6 10MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15074786
• Report Number: 1818910-2022-13641
• Device Sequence Number: 5527215
• Product Code: NJL
• UDI-Device Identifier: 10603295056034
• UDI-Public: 10603295056034
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1517-10-610
• Device Catalogue Number: 151710610
• Device Lot Number: 9898437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 07/29/2022; 09/12/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/01/2022; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CEMENTED STEM 14X50MM; ATTUNE CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 10MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB AUG RM/LL SZ 5/6 15MM; ATUN TIB SLV M/L 29MM FULL POR; ATUNE REV RP TIB BASE SZ 6 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male