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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 LEFT SIZE 6 PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 6 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scar Tissue (2060); Swelling (2091); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Udi : (b)(4). Concomitant medical products: associated products : item#:42532006701;tibia cemented 5 degree stemmed left size d; lot#:63949792. Item#:42512100414;articular surface medial congruent (mc) left 14 mm ; lot#:63788567. Item#:42540000032;all poly patella cemented 32 mm ; lot#:64239743. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted. 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: 3007963827 - 2020 - 00241, 3007963827 - 2020 - 00242, 0002648920 - 2020 - 00432.

 
Event Description

It was reported that patient underwent left total knee arthroplasty approximately 2 years ago. Subsequently, patient experienced pain and swelling since her procedure. Patient underwent manipulation under anesthesia three months after initial procedure, where the surgeon went in and bent and broke things lose in her knee, this did not help. Patient underwent a second manipulation 2 months after her first mua, which was orthoscopicly to remove scar tissue, this did not help either and the scar tissue grew back worse than before. Patient cannot bear weight and continues to walk with a cane. Patient has undergone allergy testing and is highly reactive to nickel.

 
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Brand NameFEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD LEFT SIZE 6
Type of DevicePROSTHESIS, 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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10586407
MDR Text Key208535959
Report Number3007963827-2020-00240
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 09/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42502606001
Device LOT Number63819910
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/18/2017
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: 09/25/2020 Patient Sequence Number: 1
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