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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. BMT GB KNEE STM 12X40 PROSTHESIS KNEE Back to Search Results
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.
 
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Brand NameBMT GB KNEE STM 12X40
Type of DevicePROSTHESIS 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 Key14565947
MDR Text Key293092759
Report Number0001825034-2022-01320
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K142933
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model NumberN/A
Device Catalogue Number148142
Device Lot Number485110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/01/2022 Patient Sequence Number: 1
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