MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 5 18MM; KNEE TIBIAL INSERT

Model Number	1517-10-518
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2022
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
Patella losening, change insert 18mm begining of wear lateral attune revision right.Patient status/ outcome / consequences.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.(b)(6).Device property of: none.Device in possession of: none.(b)(6).Device property of: none.Device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst: true.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicates that the loosening interface was bone to cement.
Event or Problem Description
Additional information received indicated that there was no surgical delay and the affected side was the left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.Review of the x-ray evidence was not able to confirm he complaint.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; a manufacturing records evaluation (mre) was not performed as no lot number was able to be retrieved for this device.

• Brand Name: ATTUNE CRS RP INSRT SZ 5 18MM
• 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: 15751618
• Report Number: 1818910-2022-22350
• Device Sequence Number: 6321367
• Product Code: NJL
• UDI-Device Identifier: 10603295055969
• UDI-Public: 10603295055969
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup,Followup
• Report Date (Section B): 11/08/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1517-10-518
• Device Catalogue Number: 151710518
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 11/24/2022; 12/02/2022; 12/07/2022; 01/16/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 11/28/2022; 12/06/2022; 12/14/2022; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 CRS RP INSRT SZ 5 18MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE MEDIAL DOME PAT 38MM; COMPETITOR BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male