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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 legal the patient underwent a right knee arthroplasty.The patient was revised 3 years later due to pain and 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
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: pain, post op pain problems which was thought to be sympathetic dystrophy but did well later with a well functioning knee.On (b)(6) 2017 developed pain, x-rays showed osteolysis around the implants.Femoral component removed easily, tibia which only had a little bit of need for use of a flexible osteotome to break the bond of the cement around the cortical rim and remainder popped out with ease.Fibrous tissue around implants removed.Patellar button had signs of osteolysis underneath and was removed easily.No complications noted with 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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: 11694656
• Report Number: 0001825034-2021-01092
• Device Sequence Number: 16917963
• Product Code: LOD
• UDI-Device Identifier: 00880304560789
• UDI-Public: 00880304560789
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K051496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• 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: 02/29/2016
• Device Model Number: N/A
• Device Catalogue Number: 402282
• Device Lot Number: 510390
• 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: ITM# 183442 VNGD CR TIB BRG 12X71/75LOT#UNK; UNKNOWN FEMORAL SCREW; UNKNOWN POLY PATELLA; UNKNOWN POLY TIBIAL INSERT; UNKNOWN TIBIAL BASE PLATE; UNKNOWN TIBIAL SCREW; UNKNOWN VANGUARD FEMUR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 45 YR