MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE FEM POR CR RT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Catalog Number	150401207
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent total knee replacements on (b)(6) 2023.Both of the prosthetics failed to adhere and were completely loose having subsequent surgeries.The patient experienced pain, limited mobility, and complications.This complaint, (b)(4), captures the tkr right on (b)(6) 2024.This product complaint is related to (b)(4), which captures the tkr right on (b)(6) 2023.
Additional Manufacturer Narrative
Product complaint # (b)(4) depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.D4: udi: as the catalog/model number was not provided, the (01) gtin is not available.H3, h6: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.H11 additional narrative: added: g4 and h4.Corrected: d1, d2, d4 and h6 (health effect - impact code, health effect - clinical code and medical device problem code).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: no device associated with this report was received for examination.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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.H11 additional narrative: added: d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE FEM POR CR RT SZ 7
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21157932
• Report Number: 1818910-2025-00889
• Device Sequence Number: 7655891
• Product Code: MBH
• UDI-Device Identifier: 10603295041504
• UDI-Public: (01)10603295041504(17)320430(10)3743906
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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 Catalogue Number: 150401207
• Device Lot Number: 3743906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 01/17/2025; 01/29/2025; 05/13/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/28/2025; 01/30/2025; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FEM POR CR RT SZ 7; UNKNOWN BONE CEMENT; UNKNOWN KNEE TIBIAL INSERT; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male