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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00085, 3007963827-2020-00086, and 0002648920-2020-00179.Concomitant medical products: femur cemented cruciate retaining (cr) narrow left size 6 catalog#: 42502006001 lot#: 64116798, articular surface medial congruent (mc) left 10 mm height catalog#: 42512100410 lot#: 64164251, natural tibia trabecular metal two-peg porous fixed bearing left size d catalog#: 42530006701 lot#: 64050819.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 a left total knee arthroplasty.Subsequently, she had a closed manipulation at approximately 4 weeks postop and a closed manipulation under anesthesia (mua) approximately three months later, with hospital admission for aggressive pt and continuous cpm due to ongoing postoperative arthrofibrosis and limited rom.The outcome remains pending.
 
Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, and h10.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: at six-month post op patient had flexion 94/extension 6 and underwent closed manipulation.Radiographs show no evidence of gaps between bone/ implant interface.Approximately four months¿ post op patient had range of motion from 12-56 and underwent mua.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
ALL POLY PATELLA CEMENTED 32 MM DIAMETER
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key9842050
MDR Text Key187592293
Report Number0002648920-2020-00179
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 06/10/2020
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 Number42540000032
Device Lot Number64181002
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/21/2020
Initial Date FDA Received03/17/2020
Supplement Dates Manufacturer Received06/09/2020
Supplement Dates FDA Received06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight54
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