MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEG DIST FEM SIZE B RT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Damage to Ligament(s) (1952); No Information (3190)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: stem extension straight 12mm dia x 100mm length (combined length 145mm) item#: 00598801012, lot# 64080937.Polyethylene insert xt size b use with distal femoral xt size b use with xt only item#: 00585001296, lot#: 64036066.Segment with male/female taper 30 mm length, item#: 00585004603, lot#: 64036552.Fluted stem extension straight precoat 14 mm diameter 130 mm length item#: 00585205014, lot#: 63793365.Tibial component precoat size 5 item#: 00588000500, lot#: 63753875.All poly patella standard size 38 mm diameter 9.5 mm thickness cemented item#: 00597206538, lot#: 63289114.Stem collar 35 mm o.D.For use with 16 mm or smaller diameter segmental stems item#: 00585204035, lot#: 63720636.Articular surface with segmental hinge post size b 12 mm height item#: 00585002012, lot#: 63953180.Report source- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation at this time as the device is still currently implanted.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 is scheduled for a revision due to implant fracture.There is no additional information available at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.A segment femoral component and an articular surface were returned.Visual inspection identified minor scratches on both implants.No further damage identified.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.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.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2020-00881 updated: b2, b3, b4, b5, d7, d11, e1, e2, e3, g4, g7, h1, h2, h3, h6, and h10.H3- customer has indicated that the product will not be 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 Description

It was reported that a patient was revised approximately one year and three months post implantation due to ligament laxity.The patient had complained in clinic of his knee ¿not feeling right¿, so an evaluation was carried out under c-arm visualization.At this investigation it appeared to the surgeon that there was significant opening at the joint line, and so it was assumed that the femoral hinge axle had broken.The patient is a robust (strong, not obese) male, fifty nine years old, and the surgeons guessed that he may have over-stressed the implant beyond what would be normal for a salvage prosthesis.At the revision surgery, while the patient was under anesthetic, the surgeon again assessed joint laxity and confirmed that revision was necessary for the reason anticipated above.However, upon accessing the joint we noted that there was no sign of metallosis which would reasonably be expected in the presence of a fractured implant.The hinge locking cap was removed, and the axle was withdrawn intact, straight, and not broken! all other visible parts of the construct were examined closely and were likewise shown to be intact and in relatively pristine condition.Therefore, the decision was made to disengage, remove and exchange the femoral component and exchange the articular surface.

• Brand Name: SEG DIST FEM SIZE B RT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9746036
• MDR Text Key: 188403280
• Report Number: 0001822565-2020-00668
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024195936
• UDI-Public: (01)00889024195936
• Combination Product (y/n): N
• PMA/PMN Number: K150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585004202
• Device Lot Number: 64073213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 91