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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure three months post implantation due to recurrent dislocation.The tibial components were revised while the femoral components remained intact.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: optipac 60 refob bone cmt r-3, catalog # 4711500396-3, lot # unk; unk femoral stem, catalog # unk, lot # unk; oss 7cm seg ellipt femoral rt, catalog # 150356, lot # 761990; oss poly femoral bushings, catalog # 150477, lot # 66184050; oss axle, catalog # 150480, lot # 66097344; oss poly lock pin, catalog # 150478, lot # 65676154; oss reinforced yoke, catalog # 150493, lot # 66077093; oss tib blk aug 10x63/67 univ, catalog # 150426, lot # 66008034; oss tib blk aug 10x79/83 univ, catalog # 150428, lot # 696020; oss non-mod tib plate long 63, catalog # 150419, lot # 66153805; oss poly tibial bushing, catalog # 150476, lot # 65733841.G2: belgium.H3: customer has indicated that the product will not be returned because product location is unknown.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.Reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates there is revision of right tka for recurrent dislocation of oss-type hinged knee prosthesis.Removal of the hinge, easy removal without bone damage of the tibial implant.Tibial replacements cemented without complication.Placement of the locked hinge on the femur and tibia.If any further information is found which would change or alter any conclusions or information, a supplemental 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.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.D10: refobacin cement ref (b)(4).Lot aw29be0809.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OSS TIBIAL POLY BEARING
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20629825
• Report Number: 0001825034-2024-02622
• Device Sequence Number: 15489765
• Product Code: JDI
• UDI-Device Identifier: 00880304239388
• UDI-Public: (01)00880304239388(17)280314(10)65790754
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 04/08/2025

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: 150410
• Device Lot Number: 65790754
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 11/18/2024; 04/02/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/26/2024; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown