MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS AVL TIBIAL LOCK RING; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: oss avl tib bearing catalog # 161070 lot # 887100 oss reinforced yoke catalog # 150493 lot # 66077093 optipac 60 refob bone cmt r-3 catalog # 47115003963 lot # aw33bf1610 oss tib block 20x63/67 mr/ll catalog # 150429 lot # 603480 oss tib blk aug 10x63/67 univ catalog # 150426 lot # 941290 oss avl tib oss tape 63 long catalog # 161086 lot # 333410 oss poly femoral bushings catalog # 150477 lot # 66184050 oss axle catalog # 150480 lot # 66097344 oss poly lock pin catalog # 150478 lot # 65676154 unk femoral stem catalog # unk lot # unk oss 7cm seg ellipt femoral rt catalog # 150356 lot # 761990 optipac 60 refob bone cmt r-3 catalog # 4711500396-3 lot # unk g2: belgium h3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure four months post implantation due to complete dislocation on the femoral side and a fracture of one of the components.Attempts to obtain additional information have been made; however, no more is available at this time.
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 bone cement r, ref: (b)(4), lot: aw29be0809.
Event or Problem Description
It was reported patient underwent a revision procedure four months post implantation due to complete dislocation on the femoral side and a fracture of tibial component.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of implantation and the implant is broken thought the center of the device.The locking ring was submitted for further analysis.Analysis determined the fracture surface exhibited beach marks artifacts, suggesting that the device possibly fractured due to fatigue mode of failure.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 x-ray showing the prosthesis still well in place but with a break of one of the avl component.Also x-rays showing a complete dislocation of the femoral side.Radiographs review indicates there is initial anatomic alignment of the right knee arthroplasty with a metallic object posteriorly.Later image demonstrates interval dislocation of the arthroplasty with a fractured tibial implant as noted.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.

• Brand Name: OSS AVL TIBIAL LOCK RING
• 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: 20629816
• Report Number: 0001825034-2024-02621
• Device Sequence Number: 8038885
• Product Code: KRO
• UDI-Device Identifier: 00880304456181
• UDI-Public: (01)00880304456181(17)310519(10)839670
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K051570
• 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): 04/14/2025

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: 161073
• Device Lot Number: 839670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; 04/09/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/26/2024; 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 0001825034-2024-02446
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown