MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE RP TIB BASE SZ 5 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611005
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Laxity (4526)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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
Pt had a tibial fracture at time of primary implant.
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: b5, d4 (udi, expiration, lot), g4 (pma), h4, h6 clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.B3, d1, d2a, d2b, d4 catalog, h6 (impact, problem code).
Event or Problem Description
Additional information was received: 1.Pt had a tibial fracture at time of primary knee surgery.Surgeon stated fracture was stable at time of primary surgery and x-rays looked good.2.Fracture was noticed by assistance post implant insertion but was stable and nothing to be done about it other than pt to touch weight bare.3.As quoted from the surgeon today ¿x-ray post surgery showed the fracture was stable and implants looked good.Post surgery the knee was put into hyperextension by the physiotherapist which caused subsidence of the implant.4.Tibia fracture occurred at time of primary implant.Surgeon stated that the implant was stable post surgery and in x-ray.The tibial subsidence occurred post a photo putting the knee into hyperextension.
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 that 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: pt had a tibial fracture at time of primary implant.The product was not returned to depuy synthes, however photos were provided for review.See attachment img_3264, img_3263, img_3265.The x-ray investigation found that the tibia can be seen fractured, confirming the reported allegation.However, there is no evidence that would suggest that a device malfunction would contribute to the reported adverse event.The investigation for the observed migration of the attune rp tib base sz 5 por was performed under (b)(4).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.However, there is no evidence that would suggest that the attune rp tib base sz 5 por would contribute to the reported adverse event.Based on the investigation findings, 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 reported 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: a manufacturing record evaluation was performed for the finished device 150611005/4131282 number, was manufactured on 16-apr-2023.(b)(4) parts were manufactured per specification and all raw materials met specification.

• Brand Name: ATTUNE RP TIB BASE SZ 5 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18977998
• Report Number: 1818910-2024-06609
• Device Sequence Number: 6498223
• Product Code: NJL
• UDI-Device Identifier: 10603295416272
• UDI-Public: 10603295416272
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 03/26/2024
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 150611005
• Device Lot Number: 4131282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 04/01/2024; 03/19/2024; 05/28/2024; 06/14/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/05/2024; 04/18/2024; 05/30/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female