MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 7 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-207

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problem Not Applicable (3189)

Event Date 12/24/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After taking out the implant from the package, the customer tried to put the implant on the bone of the patient.But it didn't fit at all so that he couldn't use of it.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary no product was received back for investigation.All in process inspections were conducted and passed.Based on this, it can be concluded that the part was manufactured according to the required specifications.Based on this review, no further action is required at this time, however further occurrences of this failure mode will be monitored.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch 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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

Manufacturer Narrative

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.The device associated with this report was returned to depuy cork manufacturing site for evaluation, additionally photographs were provided.The investigation performed can confirm the reported allegation, the device did not meet the dimensional specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The photographs provided do not represent the current complaint condition.The device associated with this report was returned to depuy cork manufacturing site for evaluation.The device did not meet the dimensional specifications, the complaint failure mode concerned ap spread failure -part will not fit on the bone.The root cause can be attributed to human error due to missed inspection.The overall complaint was confirmed as the observed condition of the [attune ps fem rt sz 7 cem] would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to manufacturing.The product issue has been addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FEM RT SZ 7 CEM
• Type of Device: ATTUNE IMPLANT : 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9623404
• MDR Text Key: 189332059
• Report Number: 1818910-2020-02715
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041788
• UDI-Public: 10603295041788
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K111433
• 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,Followup
• Report Date: 01/09/2020

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 Model Number: 1504-10-207
• Device Catalogue Number: 150410207
• Device Lot Number: 9053177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 04/24/2020; 09/14/2021; 03/31/2023
• Supplement Dates FDA Received: 04/27/2020; 09/21/2021; 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2019
• 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