MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT POR TIBIAL TRAY SZ3; MBT TIBIAL TRAY : KNEE TIBIAL TRAY

Catalog Number	129432130
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Joint Contracture (4528); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has had a knee replacement- on- (b)(6) 2021.Started having issues unable to do physical therapy due to extreme pain.Went 9 months until he had an additional surgery.He had to have a second surgery on this same knee and told him that a piece fell apart.He wants to let someone know that his first knee replacement was a failure.Additional information received dated sep 16, 2024: on (b)(6) 2021, the patient had a right total knee arthroplasty.The patient was revised on (b)(6) 2023 to address pain and limited mobility as well as possible infection.Patient stated that one of the pieces "broke off", but was not certain which piece broke.Depuy components were removed and depuy components were implanted during this procedure.Doi: (b)(6) 2021.Dor: (b)(6) 2023.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.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.
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 hat 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: b1 (is product problem), b5, b7 and h6 (health effect - clinical code).Corrected: h6 (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.
Event or Problem Description
Medical records received.On (b)(6) 2022, the patient had a right total knee arthroplasty to address osteoarthritis.Depuy components were implanted during this procedure.09/13/2022 medical records note the patient has right knee pain, swelling, moderate effusion, walks with a limp.On (b)(6) 2023, the patient had a revision right total knee to address mechanical loosening of internal right knee prosthetic joint.Depuy attune components were implanted along with competitor cement.It as noted that the patient had extensive scar tissue and contracture.The tibial tray was grossly loose.No interface was provided but was implied that it was the cement /implant as the surgeon had to work to remove cement from bone.Components implanted are stryker tibial symmetric cone augment, competitor cement, and depuy.(b)(6) 2024 quad atrophy was noted on ct, but no indication of any treatment.(no new pc required as there was no indication that this was a new issue).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Product description:- mbt por tibial tray sz3.Product code:- 129432130.Lot no:- 3638558.Quantity of manufactured:- (b)(4).Date of manufacturing:- 12-nov-2021.Expiry date:- 31-oct-2026.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 = > product description:- mbt por tibial tray sz3.Product code:- 129432130.Lot no:- 3638558.Quantity of manufactured:- (b)(4).Date of manufacturing:- 12-nov-2021.Expiry date:- 31-oct-2026.Device history review = > a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: MBT POR TIBIAL TRAY SZ3
• Common Device Name: MBT TIBIAL TRAY : 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 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20279528
• Report Number: 1818910-2024-19958
• Device Sequence Number: 18013606
• Product Code: NJL
• UDI-Device Identifier: 10603295025696
• UDI-Public: (01)10603295025696(17)261031(10)3638558
• 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: 2021
• Device Explanted 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
• Report Date (Section B): 09/23/2024

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 Catalogue Number: 129432130
• Device Lot Number: 3638558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 04/24/2025; 05/26/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/06/2024; 05/06/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2021
• 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: LCS COMP RP AOX INS LG 10; LCS COMPLETE FEM POR R LG; LCS COMPLETE M/B PAT POR LG; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown