MAUDE Adverse Event Report: BIOMET UK LTD. RHK 12X80 CEMENTED STEM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Degraded (1153); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Synovitis (2094); Metal Related Pathology (4530)

Event Date 05/10/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign-germany.Item name: rhk 12x80 cemented stem item#: 159405 lot#: 2084361.Item name: biomet tib block 6mm 63 item#: 141741 lot#: 639830.Item name: biomet tib block 6mm 63 item#: 141741 lot#: 203910.Item name: vngd sskpsc tib brg s 12x63/67 item#: 183822 lot#: 486500.Item name: agc mod tib locking screw item#: 153103 lot#: 089550.Item name: offset tib tray 5.0mm adaptor item#:141491 lot#: 551170.Item name: biomet offset tibial tray 63mm item#: 141481 lot#: 640750.Item name: vngd dist fem aug 60x5 rl/lm item#: 184102 lot#: 558410.Item name: vngd dist fem aug 60x5 ll/rm item#:184122 lot#: 346530.Item name: vngd ssk psc intlk fmrl 60 rt item#: 183302 lot#: 667480.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a patient underwent a total knee arthroplasty.Approximately eight years and two months post implantation, the patient underwent revision surgery due to loosening of the femoral components with a periprosthetic fracture of the femoral condyle.During the revision procedure, the surgeon noted synovitis and metallosis and a dislocation of the tibial plateau to the offset adapter.All components were revised.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).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.A review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records and radiographs were provided and reviewed by a health care professional which identified the following: revision due to stem loosening on the femoral side with a periprosthetic fracture of the femoral condyle.During surgery found synovitis with metallosis, femoral component was completely loose with fractured and disjointed femoral condyles, a dislocation of the tibial plateau to the offset adapter, a proximal fracture was seen during insertion of the rs socket, and a fracture of bone fragment was seen along the tip of the femoral shaft.The x-rays showed evidence of cortical thickening within the proximal tibial diaphysis suggests loosening of tibial component.Overall fit and alignment of the implant is appropriate on the initial study but suggests loosening on the later study.Radiolucency at the bone cement interface and worsening osteopenia may have led to loosening of the components which likely led to the revision surgery.A definitive root cause cannot be determined.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 Description

No further event information available at the time of this report.

• Brand Name: RHK 12X80 CEMENTED STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15317903
• MDR Text Key: 298874287
• Report Number: 3002806535-2022-00363
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 05019279751976
• UDI-Public: (01)05019279751976(17)200915(10)2114452
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2020
• Device Model Number: N/A
• Device Catalogue Number: 159405
• Device Lot Number: 2114452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female