MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of birth: (b)(6).Concomitant medical product(s): cement palacos r+g 2.40 haraeus (b)(4); femoral cone s left 30mm 'm210005450017301-2018263041242f15g; femoral cone s left 35mm 'm210005450020351-2018263069816g15x#; femoral size d left 'h124005880014011-2112063141764e16k; nexgen distal femoral size d 5mm augment 'h124005990034101-2603163255787a16.Rotating hinge knee tibial size 3 'h124005880003001-2115163361781e16o; nexgen straight long stem 12mmx 155mm 'h124005988011121-2127361875577i117; rotating hinge knee size d 14 mm height 'h124005880040141-2033563224821l15w; nexgen distal femur block size d 5mm augment 'h124005990034101-2524363144330h15s; tibial cone m 36mm x31mm x 25mm height 'm210005450013361-1909062618510c14r; nexgen tibial block size 4 5mm thickness 'h124005988004261-2406062620396b14; nex gen tibial block size 4 5mm 'h124005988004261-2406062620396b14; nex gen posterior femoral augment block size d 10mm augment 'h124005990034021- 2133461922932k11y; nex gen posterior femoral augment block size d 10mm augment 'h124005990034021- 1909061210909c09z; nex gen stem straight 1mm dia x 100mm long 'h124005988010111-2603163245728a16x.Report source: foreign country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the hinge post extension and hinge post were fractured.The devices also exhibited deformations and wear consistent with third body debris.Fracture analysis of the hinge post and hinge post extension showed that they fractured due to fatigue.Elemental analysis of the hinge post and hinge post extension identified the material was consistent with print specifications.The device history record (dhr) was reviewed and no discrepancies were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified no complications in the rhk implantation surgery.No medical records from the revision surgery were provided.Review of the provided x-rays identified metallic fragments were present along the medial compartment of the knee.Per the nexgen rhk package insert instability and fracture are known potential adverse effects of this procedure.A definitive root cause cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04378.
Event or Problem Description
It was reported patient¿s knee was revised approximately one day post implantation due to instability and implant fracture.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9920931
• Report Number: 0001822565-2020-01268
• Device Sequence Number: 3257205
• Product Code: KRO
• UDI-Device Identifier: 00889024199125
• UDI-Public: (01)00889024199125
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00588001401
• Device Lot Number: 63141764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 04/03/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 75