MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AGC MOD TIB LOCKING SCREW; PROSTHESIS, KNEE

Catalog Number 153103

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Synovitis (2094); Osteopenia/ Osteoporosis (2651); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 05/10/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth: patient was born in 1937.Concomitant medical products:: vngd ssk psc intlk fmrl 60 rt: catalog#183302, lot#667480; vngd dist fem aug 60x5 ll/rm: catalog#184122, lot#346530; vngd dist fem aug 60x5 rl/lm: catalog#184102, lot#558410; rhk 12x80 cemented stem: catalog#159405, lot#2114452; biomet offset tibial tray 63mm: catalog#141481, lot#640750; offset tib tray 5.0mm adaptor: catalog#141491, lot#551170; rhk 12x80 cemented stm: catalog#159405, lot#2084361; biomet tib block 6mm 63: catalog#141741, lot#639830; biomet tib block 6mm 63: catalog#141741, lot#203910; vngd sskpsc tib brg s 12x63/67: catalog#183822, lot#486500; copal g+c cement 1x40: catalog#66017790, lot#76974354.Report source: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2022-01960; 0001825034-2022-01961; 0001825034-2022-01962; 0001825034-2022-01963; 0001825034-2022-01964.Diligence is in progress to determine if the products will be returned to zimmer biomet for evaluation.The investigation is in process.Once the investigation has been completed, a follow-up mdr 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 aseptic loosening of the femoral components with a periprosthetic fracture of the femoral condyle.During the revision procedure, the surgeon noted significantly soft bone, synovitis and metallosis.The tibial stem was difficult to remove which resulted in a tibial fracture and unintended disassociation of the tibial stem and 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

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records and radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: right total knee arthroplasty with suggestion of loosening of both the tibial and femoral components.Associated cortical thickening within the distal femoral diaphysis and proximal tibial diaphysis suggests loosening as well.Worsening osteopenia.Root cause was unable to 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 Description

No further event information at time of this report.

• Brand Name: AGC MOD TIB LOCKING SCREW
• Type of Device: 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: 15319283
• MDR Text Key: 298873192
• Report Number: 0001825034-2022-01965
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K945028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 153103
• Device Lot Number: 089550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female