MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS FEMORAL LT SZ 5 CEM; KNEE FEMORAL

Catalog Number 150440105

Device Problem Device-Device Incompatibility (2919)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  malfunction  

Event Description

It was reported that femur did not seat or fit like trial femurs had and patient experienced large variance on medial side that was not present in any of the prep or trialing phases.Doe: (b)(6) 2024 affected side: left knee.

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.

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 that 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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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.H10 additional narrative: added: a1, a3, b5, h6 (clinical code, impact code) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information was received: surgery was delayed, we probably spent 45 min re assessing our cuts and re-prepping out femoral canal to ensure we weren't being hung up in that aspect.The final result while not giving a visible perfect fit, was a balanced knee that the patient has been happy with in the early post op follow ups.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "it was reported that femur did not seat or fit like trial femurs had and patient experienced large variance on medial side that was not present in any of the prep or trialing phases.Doe: (b)(6), 2024 / affected side: left knee".The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the outer surface/polish area of the attune crs femoral lt sz 5 cem exhibits what appears to be light scratches along the area of the condyles, mots likely due to the insertion attempts.Additionally, a small amount of cement residues were found in the fixation surface of the condyles.No defects that could have contribute to the reported event were observed.A dimensional inspection was performed for the femoral component and met specifications.A manufacturing record evaluation was performed for the finished device [150440105 / j9409m] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the attune crs femoral lt sz 5 cem would 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 reported 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.Drawing/specifications reviewed? dwg-1150440105 rev.F current and manufactured.Dimensional inspection: specified dimensions: device width, area of the condyles = 66.50mm.Device width, inner area = 20.50mm + 0.40 -0.25mm.Gap between condyles = 16.50 +/- 0.05mm.Central post ø = 10.40mm +/- 0.13mm.Measured dimensions: device width, area of the condyles = 66.50mm (complies).Device width, inner area = 20.51mm (complies).Gap between condyles = 16.49 mm (complies).Central post ø = 10.39 mm (complies).Device used ¿ digimatic caliper cd78621.Device history lot: a manufacturing record evaluation was performed for the finished device [150440105 / j9409m] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : according to the information received, "it was reported that femur did not seat or fit like trial femurs had and patient experienced large variance on medial side that was not present in any of the prep or trialing phases.Doe: (b)(6) 2024 / affected side: left knee".The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the outer surface/polish area of the attune crs femoral lt sz 5 cem exhibits what appears to be light scratches along the area of the condyles, mots likely due to the insertion attempts.Additionally, a small amount of cement residues were found in the fixation surface of the condyles.No defects that could have contribute to the reported event were observed.A dimensional inspection was performed for the femoral component and met specifications.A manufacturing record evaluation was performed for the finished device [150440105 / j9409m] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was not confirmed as the observed condition of the attune crs femoral lt sz 5 cem 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 reported 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.Drawing/specifications reviewed? dwg-1150440105 rev.F current and manufactured.Dimensional inspection: specified dimensions: device width, area of the condyles = 66.50mm.Device width, inner area = 20.50mm + 0.40 -0.25mm.Gap between condyles = 16.50 +/- 0.05mm.Central post ø = 10.40mm +/- 0.13mm.Measured dimensions: device width, area of the condyles = 66.50mm (complies).Device width, inner area = 20.51mm (complies).Gap between condyles = 16.49 mm (complies).Central post ø = 10.39 mm (complies).Device used ¿ digimatic caliper cd78621.Device history lot:a manufacturing record evaluation was performed for the finished device [150440105 / j9409m] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: ATTUNE CRS FEMORAL LT SZ 5 CEM
• Type of Device: KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18720939
• MDR Text Key: 335580162
• Report Number: 1818910-2024-03520
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042181
• UDI-Public: 10603295042181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• 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,Followup,Followup,Followup
• Report Date: 02/16/2024

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: 150440105
• Device Lot Number: J9409M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/24/2024; 03/18/2024; 04/02/2024; 04/29/2024
• Supplement Dates FDA Received: 02/28/2024; 03/20/2024; 04/04/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• 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
• Patient Sex: Female