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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 35 MM DIAMETER PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 35 MM DIAMETER PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Device Damaged by Another Device (2915); Material Integrity Problem (2978)
Patient Problem No Code Available (3191)
Event Date 12/07/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products; patella clamp head item# 00590302100 lot# 64298299. Report source: (b)(6). Customer has indicated that the product will be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported during the initial total knee arthroplasty, when clamping the patella during cementing, the patella was indented by the patella clamp. Patella was removed and replaced with another patella the same size with a different clamp. There is no additional information at this time.

 
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Brand NameALL-POLY PATELLA CEMENTED 35 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 Key9536444
MDR Text Key173278366
Report Number0002648920-2019-00904
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42540200035
Device LOT Number64435173
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 Received05/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/27/2019
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: 12/31/2019 Patient Sequence Number: 1
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