MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS POLY TIBIAL BUSHING; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product(s): 150410 - oss tibial poly bearing 12mm - 050720; 150493 - oss reinforced yoke - 826110; 150478 - oss poly lock pin - 530340; 150480 - oss axle - 632970.Report source, foreign country: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00787; 0001822565-2023-00972.
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty.Subsequently, they suffered a fall and underwent a revision surgery approximately 2 months later due to implant dislocation.The articular surface and hinge were replaced.It is unknown when and how the patient fell.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.X-ray review by third party hcp states that there is complete dislocation of a left total knee arthroplasty.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
It was reported that the patient was implanted with a left knee oss system.Subsequently, the patient's patella continued to dislocate laterally.An adjustment procedure was performed as well as a removal of lateral patellar retinaculum and implantation of extension knee brace.Approximately 15 days after the adjustment, the left knee gave away while the patient was not wearing knee brace and the patient fell resulting in an open dislocation.The patient was subsequently revised where the final insert was placed.During the revision, a partial detachment of vastus lateralis was found and an exploration of the lateral patellar retinaculum was performed with improvement to stability of the patella.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a4; b4; b5; b7; d2; g1; g3; g6; h1; h2.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3.The event is confirmed.Medical records were provided and reviewed by a healthcare professional.The notes state that there was excessive internal rotation of the tibial implant thought to be the source of the patella dislocation.The patient was reported to have a fall without the brace.There was anterior displacement of femoral implant and open dislocation of knee joint and natural patella was found to be dislocated.Root cause remains unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OSS POLY TIBIAL BUSHING
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16713793
• Report Number: 0001822565-2023-00973
• Device Sequence Number: 16556358
• Product Code: JDI
• UDI-Device Identifier: 00880304002258
• UDI-Public: (01)00880304002258(17)270321(10)724780
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/03/2025

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 Model Number: N/A
• Device Catalogue Number: 150476
• Device Lot Number: 724780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 05/08/2025; 06/16/2025; 10/02/2025
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 10/13/2023; 05/21/2025; 06/19/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 133 KG