MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK PSC TIB BRG 10X71/75; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 141490 - offset tib tray adaptor - 752210; 184764 - series a pat std - 674220; cp113125 - vngd ti fem ssk - 486890; 141658 - bmt splined knee stm - 082360; 141483- biomet offset tibial tray - 154000; 141616 - bmt splined knee stem - 901020; 110035368 - biomet bc r 1x40 us - 743cah1407; 110035368 - biomet bc r 1x40 us - 826aac2203.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.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: 0001825034-2022-00141, 0001825034-2022-00143, 0001825034-2022-00144, 0001825034-2022-00145, 0001825034-2022-00147.
Event or Problem Description
It was reported that the patient underwent a revision surgery approximately 2.5 years post implantation due to pain, loosening, metal debris, and limited mobility.During the revision, blackened synovium with metal debris was noted.The femur, tibia, tibia adapter, stems, and bearing were exchanged without complications.The patella remained intact.Attempts have been made and no further information has been provided.
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.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review found patient presented with left knee pain.X-ray review found loosening.During the revision procedure blackened synovium was found in the joint space due to metal debris.The tibial tray was loose with motion between the tray and the morse taper for the stem (disassociation would have occurred between the offset adapter and stem).X-rays were provided and reviewed by a health care professional.Review found possible metallosis noted within the posterior joint space.Overall fit and alignment of the implants is appropriate.Normal bone quality.No signs of radiolucency.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.

• Brand Name: VNGD SSK PSC TIB BRG 10X71/75
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13400669
• Report Number: 0001825034-2022-00146
• Device Sequence Number: 1716099
• Product Code: JWH
• UDI-Device Identifier: 00880304441149
• UDI-Public: (01)00880304441149(17)220414(10)740600
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 04/14/2022
• Device Model Number: N/A
• Device Catalogue Number: 183880
• Device Lot Number: 740600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Female
• Patient Weight: 95 KG