MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMT GB KNEE STM 12X40; PROSTHESIS KNEE

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 12/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown which 1 of the 2 reported devices was revised due to painful patella and femoral loosening.It is unknown which exact device encountered this issue, it is one of the following: item name: bmt gb knee stm 12x40, item#: 148142, lot#: 485110, manufacture date: sep 30, 2010, sterile expiry date: sep 30, 2020, udi: n/a, 510k: k142933, pro code: oiy.Or item name: bmt gb knee stm 14x40, item#:148144, lot#: 915370 , manufacture date: feb 27, 2014, sterile expiry date: feb 29, 2024, udi: n/a, 510k: k142933, pro code: oiy.Medical products: vngd ssk 360 femur r 67.5 catalog # 185265 lot # 6030464, series a pat w/wr thn 28 1 peg catalog # 184722 lot # 410380, series a pat thn 28 3 peg catalog # 184782 lot # 187960, bmt gb knee stm 14x40 catalog # 148144 lot # 915370, vngd ssk psc tib brg 12x63/67 catalog # 183862 lot # 427280, bmt 360 tib tray 67mm catalog # 185202 lot # 723760, bmt 360 tib sm cruciate wing catalog # 185650 lot # 712250, thin osteotome blade 8mm catalog # 430052 lot # 471937, 1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 813530, 1/8 quick rel drl sterile 2pk catalog # 32-486265 lot # 813530.Report source: (b)(6).(b)(4).Multiple mdr reports were filled for this event: 0001825034-2021-03459, 0001825034-2021-03460.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Not returned by hospital.

Event Description

It was reported patient underwent a revision procedure three years post implantation due to painful patella and femoral loosening.No further event information available at the time of this report.

• Brand Name: BMT GB KNEE STM 12X40
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14565947
• MDR Text Key: 293092759
• Report Number: 0001825034-2022-01320
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 148142
• Device Lot Number: 485110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• 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): Hospitalization; Required Intervention
• Patient Sex: Female