MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT SPLINED KNEE STM 16X80; PROSTHESIS, KNEE

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Local Reaction (2035); Metal Related Pathology (4530)

Event Date 11/12/2021

Event Type  Injury  

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 - 154000.183880 - vngd ssk psc tib brg - 740600.110035368 - 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, 0001825034-2022-00146.

Event 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10 h6: component code: mechanical (g04) - stem 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.

Event Description

No further event information available at the time of this report.

• Brand Name: BMT SPLINED KNEE STM 16X80
• Type of Device: 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: 13400642
• MDR Text Key: 287182361
• Report Number: 0001825034-2022-00147
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00880304000971
• UDI-Public: (01)00880304000971(17)290206(10)901020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141616
• Device Lot Number: 901020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 95 KG