MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE 5 DEGREES RIGHT MEDIAL/LEFT LATERAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item 42538000502 lot 64529151.Item 42558000202 lot 64623165.Item 42528200508 lot 64561694.Report source: 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: 0001825034-2021-01403.
Event or Problem 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.
Additional 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 or Problem Description
No additional event information to report at this time.

• Brand Name: TIBIAL CUT GUIDE 5 DEGREES RIGHT MEDIAL/LEFT LATERAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11783741
• Report Number: 0001825034-2021-01404
• Device Sequence Number: 847616
• Product Code: HSX
• UDI-Device Identifier: 00889024582859
• UDI-Public: (01)00889024582859(11)200320(10)64719765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42539905295
• Device Lot Number: 64719765
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other