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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 7; PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 7; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problems Pain (1994); Weight Changes (2607); Swelling/ Edema (4577)
Event Date 03/08/2021
Event Type  Injury  
Event Description
It was reported a patient was converted from a right medial uncompartmentalized knee to a right total knee.Subsequently, the patient is experiencing ongoing pain, swelling, radiolucency at the medial tibial plateau, and possible instability.Anti-inflammatory gel and steroids were prescribed to relieve the symptoms.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00185, 0002648920-2022-00162, 0001822565-2022-02099, 0001822565-2022-02100 and 0001822565-2022-02101.
 
Event Description
No further event information available at the time of this report.
 
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: proposed component code: mechanical (04) - femur.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 of the available records identified the following: swelling, possible instability, full rom, prescribed medication for swelling, x-rays show radiolucency in the medical tibial plateau.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.
 
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Brand Name
FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 7
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI 
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI  
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key15026370
MDR Text Key295954538
Report Number3007963827-2022-00184
Device Sequence Number1
Product Code MBH
UDI-Device Identifier00889024230361
UDI-Public(01)00889024230361(17)280731(10)63977741
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/04/2022
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 Model NumberN/A
Device Catalogue Number42502606202
Device Lot Number63977741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/24/2022
Initial Date FDA Received07/15/2022
Supplement Dates Manufacturer Received09/29/2022
Supplement Dates FDA Received10/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2018
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 Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
Patient Weight123 KG
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