MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEGMENTAL ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 17MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It was indicated by the complainant that the products will not be returned to zimmer biomet for investigation as they remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products ¿ nexgen rotating hinge knee precoat tibial component size 6 catalog #: 00588000600 lot #: 62648340, segmental polyethylene insert size c catalog #: 00585001395 lot #: 62937986, segmental distal femoral component size c left catalog #: 00585001301 lot #: 62595079, segmental segment with male/female taper 40mm catalog #: 00585004604 lot #: 62745110, segmental straight precoat fluted stem extension 14mm x 130mm catalog #: 00585205014 lot #: 62818230, nexgen sharp fluted long stem extension 12mm x 130mm catalog #: 00598801612 lot #: 62569207.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03494, 0001822565-2018-03497, 0001822565-2018-03500, 0001822565-2018-03501, 0001822565-2018-03502, 0001822565-2018-00521.Remains implanted.

Event Description

It was reported that the patient developed deep vein thrombosis following left knee arthroplasty and was treated with six (6) months of xarelto.No additional patient consequences were reported.

Manufacturer Narrative

The products were evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information provided.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: SEGMENTAL ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 17MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7649686
• MDR Text Key: 112704264
• Report Number: 0001822565-2018-03499
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: PK070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00585003017
• Device Lot Number: 62213601
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 97