MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COBALT HV BONE CEMENT 40G; CEMENT, BONE CEMENT

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item# 183128 item name van ps open intl fem-lt 6565 lot # j3941926; item# 183099 item name vanguard fem pegs set 2 lot # 975950; item# 184766 item name series a 3 peg std 34x8.5 lot # 304200; item# ep-183642 item name e1 vngd ps tib brg 71/75x12x 12 lot # 671170; item# 141224 item name biomet cc i-beam tray 75mm lot # j3958309.The device will not be returned for analysis location unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported by patients¿ legal counsel that the patient underwent primary left tka.Subsequently it was reported left revision of total knee two (2)years later for tibial loosening.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: 53yo obese, tibial component obviously loose ¿ explanted.Explanted femoral component w/out substantial bone loss, patella retained, no complications.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01232.

• Brand Name: COBALT HV BONE CEMENT 40G
• Common Device Name: CEMENT, BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11694309
• Report Number: 0001825034-2021-01091
• Device Sequence Number: 3095637
• Product Code: LOD
• UDI-Device Identifier: 00880304560789
• UDI-Public: (01)00880304560789(17)171130(10)05800
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K051496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 402282
• Device Lot Number: 058600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention