MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATT REV SLV LPS FEM ADP +5; KNEE FEMORAL ADAPTOR

Catalog Number	151106005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Tissue Injury (4559)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # :(b)(4).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
The patient was revised due to bone resorption at the interface of the femoral sleeve and distal femur.Surgeon was concerned that further bone loss could lead to a fracture of the distal femur and decided to revise the femoral side of the construct.Doi: (b)(6), 2022.Dor: (b)(6), 2023.Affected side: left knee.
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.H10 additional narrative: added: h6 health effect - clinical code.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
Additional information received.A.Was there loosening involved in the event? if yes, please provide the loosening component/s.Yes and as stated in the der, there was loosening at both the bone/sleeve and bone/stem interface mist likely due to metallosis from an existing femoral side plate.B.Please confirm if there was fracture of the distal femur.No, there was no fracture.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.

• Brand Name: ATT REV SLV LPS FEM ADP +5
• Common Device Name: KNEE FEMORAL ADAPTOR
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 17396281
• Report Number: 1818910-2023-15203
• Device Sequence Number: 7721503
• Product Code: MBH
• UDI-Device Identifier: 10603295503392
• UDI-Public: 10603295503392
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K202248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2023

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: 151106005
• Device Lot Number: JC8960
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 07/29/2023; 08/04/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/03/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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 REV LPS INSRT XXSM 14MM.; ATUN FEM SLV M/L 30MM FULL POR.; ATUNE PRESSFIT STR STEM14X60MM.; LPS DISTAL FEM COMP XXSM LT.; LPS SEGMENTAL COMPONENT 40MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 70 KG