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

Model Number	1504-01-207
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inadequate Osseointegration (2646)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cementless cr rp attune knee was revised for being loose.The bone scan showed the femur was loose, and upon explantation a pseudo membrane was present between implant and implant and bone interface.Dor: (b)(6) 2023, affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: 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
Additional information received: a.Was there any surgical delay related to the event? removal of implants, but within the time expected time take to revise a knee.B.Can you please provide details of the loosening interface? as described the femur, but pseudomembrane present on the tibia and femur which the surgeon suggested implied they were loose.
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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
Additional information received indicates that the affected side involved in this event was the right side.
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: 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17116403
• Report Number: 1818910-2023-12165
• Device Sequence Number: 19724519
• Product Code: MBH
• UDI-Device Identifier: 10603295041504
• UDI-Public: 10603295041504
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2023
• 2 Devices were Involved in the Event: 1 2

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: 1504-01-207
• Device Catalogue Number: 150401207
• Device Lot Number: 9679553
• 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: 05/29/2023
• Supplement Date Received by Manufacturer: 06/19/2023; 07/03/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 06/19/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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 CR RP INSRT SZ 7 8MM; ATTUNE RP TIB BASE SZ 7 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown