MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Bone Fracture(s) (1870)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item 42539905295 lot 64719765; item 42558000202 lot 64623165; item 42528200508 lot 64561694.Foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01404.

Event Description

It was reported that unicompartmental knee arthroplasty was performed with ppk; subsequently about one week after the primary operation, the patient's tibia bone cracked from a pinhole made by new type cut guide.The patient bone has been observed.A revision is not planned so far.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Radiographs were reviewed by a third party hcp and noted a vague presence of periprosthetic lucencies inferior to the tibial hardware component which could be related to developing loosening of the hardware.The 2 postoperative images demonstrate presence of newly present linear lucency inferior to the central tibial peg which could be related to a nondisplaced fracture as reported on the event/deficiency description.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01564.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 additional event information to report at this time.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11783747
• MDR Text Key: 249260890
• Report Number: 0001825034-2021-01403
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812697
• UDI-Public: (01)00880304812697(17)300131(10)64529151
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000502
• Device Lot Number: 64529151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other