MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 4 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150400204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Woman operated for knee replacement (b)(6) 2023.Attune cr femur sz 4 left, tibia sz 4, insert sz 4, 6 mm.Patient luxates the knee joint several times, and is repaired several times during a time frame of one week.Today, (b)(6) 2023 revised because the situation for the patient has become untenable.The insert was loose from the locking mechanism on tibia component when opening the knee joint.Replaced the plastic insert from 6 mm to 10 mm, and the patient is in a full leg stabilized with cement after the operation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary woman operated for knee replacement 11/10 at aleris malmö peritus clinic.Attune cr femur sz 4 left, tibia sz 4, insert sz 4, 6 mm.Patient luxates the knee joint several times, and is repaired several times during a time frame of one week, today 19/10 revised at lund university hospital because the situation for the patient has become untenable, insert is loose from the locking mechanism on tibia component when opening the knee joint, replacement of plastic insert from 6 mm to 10 mm, and the patient is in a full leg stabilized with cement after the operation.The product was not returned to depuy synthes, however photos were provided for review.See attachment "peritus attune prim rev 1, peritus attune prim rev 2" the x-ray investigation was able to identify the reported dislocation event.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.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 confirmed.As the observed condition of the attune cr fem rt sz 4 cem would contribute to the complained device issue.Based on the investigation findings, a potential cause cannot be established with he information provided and 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 the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.

• Brand Name: ATTUNE CR FEM RT SZ 4 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18047643
• Report Number: 1818910-2023-22171
• Device Sequence Number: 8026287
• Product Code: JWH
• UDI-Device Identifier: 10603295041191
• UDI-Public: 10603295041191
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 11/01/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 150400204
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 01/08/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/17/2023; 01/10/2024
• 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 CR FB INSRT SZ 4 6MM.; ATTUNE FB TIB BASE SZ 4 CEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown