MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR RT SZ 4; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number 150401204

Device Problems Off-Label Use (1494); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

Product has been recalled by j&j due to wrong implant size being in the box, the surgeon confirmed yesterday that this affected implant has been implanted into a patient.Signed field safety notice received from the hospital.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: product has been recalled by j&j due to wrong implant size being in the box, the surgeon confirmed yesterday that this affected implant has been implanted into a patient.Signed field safety notice received from the hospital is recalling the patient to advise what had happened and see if they would like it revised.The product was not returned to depuy synthes, however photos were provided for review.(b)(4) fw documentation re wrong-sized attune cementless femur].The x-ray investigation revealed that there was no damage or defects with the attune fem por cr rt sz 4.There is not enough evidence in the photo to confirm the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the observed condition of the attune fem por cr rt sz 4 would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : quantity manufactured: 12 2) date of manufacture: 12/08/2022 3) any anomalies or deviations identified in dhr: there were three nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.4) expiry date: 31/07/2032 5) ifu reference: ifu-0902-00-870 device history review: quantity manufactured: 12 2) date of manufacture: 12/08/2022 3) any anomalies or deviations identified in dhr: there were three nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.4) expiry date: 31/07/2032 5) ifu reference: ifu-0902-00-870.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information provided, "product has been recalled by j&j due to wrong implant size being in the box, the surgeon confirmed yesterday that this affected implant has been implanted into a patient.Signed field safety notice received from the hospital is recalling the patient to advise what had happened and see if they would like it revised." the product was not returned to depuy synthes, however x-rays were provided for review.(b)(4).The x-ray investigation revealed the implants were well fixed, however, there appears to be some lucency under the anterior flange of the femoral component.This is consistent with the implant having the dimensions of a size 5 and 3mm oversized compared to the bony cuts made for a size 4 implant, which resulted in the product recall.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection could not be completed.However, review of previous complaints and review of the device history records confirmed this lot 3883327 was in scope of a product recall for size 5 components packaged and labeled as size 4.A previous investigation by the manufacturing site under (b)(4), reported the size 5 component was mis-etched and packaged as a size 4.The overall complaint was confirmed as the evidence observed would contribute to the complained device issue.Based on the previous and current investigation findings, the cause is traced to manufacturing and the product issue was addressed through the depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 12/08/2022, 3) any anomalies or deviations identified in dhr: nr-0199414 is related to another confirmed complaint (b)(4) for a non-conformance that led to the recall of lot 3883327.There is a direct correlation between this nonconformance and the failure mode of the current complaint (b)(4).4) expiry date: 31/07/2032 5) ifu reference: ifu-0902-00-870.Device history review : 1) quantity manufactured: (b)(4).2) date of manufacture: 12/08/2022.3) any anomalies or deviations identified in dhr: nr-0199414 is related to another confirmed complaint (b)(4) for a non-conformance that led to the recall of lot 3883327.There is a direct correlation between this nonconformance and the failure mode of the current complaint (b)(4).4) expiry date: 31/07/2032 5) ifu reference: ifu-0902-00-870.

• Brand Name: ATTUNE FEM POR CR RT SZ 4
• Type of Device: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17684211
• MDR Text Key: 322651331
• Report Number: 1818910-2023-18109
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295041474
• UDI-Public: 10603295041474
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2023

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 Catalogue Number: 150401204
• Device Lot Number: 3883327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 11/21/2023; 11/27/2023
• Supplement Dates FDA Received: 11/21/2023; 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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