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

Model Number	1504-01-204
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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
It was reported that surgeon did a cementless attune knee this morning and cut a size 4r a size 4 femur was opened and implanted.Despite being packaged as size 4, appeared to have the dimensions of a size 5 femur externally.This was noticed as the prosthesis overhung and when measuring with a caliper seems to be a size 5 on the outer dimensions.We were unable to measure internal dimensions.The femur was also loose after implantation put it on.When the implant was removed, it is labelled as a 4r.The surgeon had to implant a 4n instead which fitted correctly and was secure.The surgeon was happy with the sizing on the m/l of the prosthesis, however would not have been able to implant a size 4r as only one was available.
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 = > the device associated with this report was returned to depuy synthes for evaluation.The overall complaint was confirmed as the observed condition of the returned device labeled and packaged as an attune fem por cr rt sz 4 contributed to the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > product description: attune fem por cr rt sz 4 product code: 150401204.Lot number: 3883327.1) quantity manufactured: 12.2) date of manufacture: 8/12/2022.3) any anomalies or deviations identified in dhr: there were two nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.4) expiry date: 7/31/2032.5) ifu reference: ifu-0902-00-870.Device history review = > 1) quantity manufactured: 12.2) date of manufacture: 8/12/2022.3) any anomalies or deviations identified in dhr: there were two nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.4) expiry date: 7/31/2032.5) ifu reference: ifu-0902-00-870 h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was returned for analysis.Visual analysis revealed that the dimension of the device not math with the speciation measure of the attune fem por cr rt sz 4 according with the drawing specification.However is not possible determinate the initial use condition of the device due to no evidence was shared for the investigation.The report condition cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed dwg-(b)(4) rev c current.Dgw-(b)(4) rev e current.Device history lot : product description: attune fem por cr rt sz 4 product code: 150401204 lot number: 3883327.1) quantity manufactured: (b)(4).2) date of manufacture: 8/12/2022.3) any anomalies or deviations identified in dhr: there were two nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.4) expiry date: 7/31/2032.5) ifu reference: ifu-0902-00-870.Device history review : 1) quantity manufactured: (b)(4).2) date of manufacture: 8/12/2022 3) any anomalies or deviations identified in dhr: there were two nonconformance recorded on this batch that was related to process controls and did not impact on the overall product.4) expiry date: 7/31/2032 5) ifu reference: ifu-0902-00-870.

• Brand Name: ATTUNE FEM POR CR RT SZ 4
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16723563
• Report Number: 1818910-2023-07749
• Device Sequence Number: 17944377
• Product Code: MBH
• UDI-Device Identifier: 10603295041474
• UDI-Public: 10603295041474
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1504-01-204
• Device Catalogue Number: 150401204
• Device Lot Number: 3883327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 06/23/2023; 08/28/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/23/2023; 06/23/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown