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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 32 MM DIAMETER PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 32 MM DIAMETER PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00211, 3007963827-2019-00212, 0002648920-2019-00527, and 0001822565-2019-02944. Concomitant medical products: femur cemented posterior stabilized (ps) standard left size 8 catalog#: 42500606401 lot#: 63791675, tibia cemented 5 degree stemmed left size f catalog#: 42532007501 lot#: 63443525, articular surface fixed bearing posterior stabilized (ps) left 12 mm height catalog#: 42512400712 lot#: 63314881. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that patient underwent left total knee arthroplasty approximately fifteen (15) months ago. Subsequently, patient is reporting swelling, pain, instability, loosening, audible noise, and general weakness of the knee. No revision procedure has been reported.

 
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Brand NameALL-POLY PATELLA CEMENTED 32 MM DIAMETER
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8796136
MDR Text Key151262573
Report Number0002648920-2019-00527
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42540200032
Device LOT Number63843853
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/27/2018
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 TREATMENT DATA
Date Received: 07/16/2019 Patient Sequence Number: 1
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