MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE CRS FEMORAL LT SZ 4 CEM; KNEE FEMORAL

Model Number	1504-40-104
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.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 on (b)(6) 2020, the patient underwent the surgery via tka.The surgery was completed successfully without any surgical delay.After the surgery, there was the possibility of metallosis due to micro-motion of the taper lock between femoral sleeve and femoral component.There was also the possibility of looseness due to metalosis.The revision surgery was done on an unknown date.The revision surgery was completed successfully without any surgical delay.The surgeon commented that it might be a loose taper lock.He want the investigation to identify the source of the metal debris.No further information is 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).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.Review of the information, photographs and physical device, the reported allegation can be confirmed.There is evidence of micromotion between the sleeve and the femoral component which could result in loosening and wear of the devices, based on the photographs provided metallosis can be seen.Additionally the femoral component presented unknown augments in the condylar area, as well as non depuy cement.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the investigation was not able to retrieve the required lot code.

• Brand Name: ATTUNE CRS FEMORAL LT SZ 4 CEM
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16371303
• Report Number: 1818910-2023-03636
• Device Sequence Number: 15268636
• Product Code: JWH
• UDI-Device Identifier: 10603295042174
• UDI-Public: 10603295042174
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1504-40-104
• Device Catalogue Number: 150440104
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 02/21/2023; 03/16/2023; 04/05/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 02/22/2023; 03/17/2023; 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 CRS RP INSRT SZ 4 16MM; ATUN FEM SLV M/L 30MM HALF POR; ATUN PRESSFIT STR STEM16X110MM; UNKNOWN KNEE FEMORAL SLEEVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male