MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MBT POR TIBIAL TRAY SZ4; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number	129432140
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
It was reported patient was revised due to loose tibia.Did the event occur during sterile processing? --> no.Did the event occur during field inspection? --> no.Did the event occur during internal service activities such as calibration? --> no.Patient status/ outcome / consequences --> no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown.Is the patient part of a clinical study --> unknown.(b)(4).Device property of -->none.Device in possession of -->none.(b)(4).Device property of -->none.Device in possession of -->none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, revision for loose tibia.¿the product was not returned to depuy synthes, however photos were provided for review.See attachment img_2578.Jpeg, img_2579.Jpeg, img_2580.Jpeg.The photo investigation revealed that the mbt por tibial tray sz4 was observed with some tissue on the implant, the duration of time the implant was in place is unknown, but it is evident that there was no good natural integration between the tissue and the implant.This which may indicate possible loosening.Which is not normal, as the body naturally integrates and absorbs it due to the spherical powder cocrmo and titanium randomly arranged on the surface of the parts to stablish initial fixation and long term stability by allowing for bone ingrowth.This demonstrates that the implant did not have fixation.With the information provided is not possible to determine a potential cause at this moment, the mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables e.G.Activity level and use, anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the mbt por tibial tray sz4 would contribute to the complained device issue.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 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 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: MBT POR TIBIAL TRAY SZ4
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18715164
• Report Number: 1818910-2024-03430
• Device Sequence Number: 3729468
• Product Code: NJL
• UDI-Device Identifier: 10603295025702
• UDI-Public: (01)10603295025702(17)121012(10)2387098
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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 Expiration Date: 10/12/2012
• Device Catalogue Number: 129432140
• Device Lot Number: 2387098
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2007
• 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: LCS COMP RP INSERT LG 17.5MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown