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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/21/2021
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical product: femur trabecular metal, item# 42502806601, lot# 64592715. Tibial augment cemented half block left lateral size ef 15 mm thickness, item# 42555805115, lot# 64628774. Tibial augment cemented half block left medial size ef 15 mm thickness, item# 42555805315, lot# 64630424. Stem extension tapered cemented 14 mm diameter +75 mm, item# 42560007514, lot# 64875941. Femur cemented standard left size 9, item# 42504606601, lot# 64890454. Stem extension tapered cemented 14 mm diameter +75 mm length, item# 42560007514, lot# 65047301. 2. 5 mm female hex screw 25 mm length, item# 42509902525, lot# 65130228. Hex headed screw 3. 5 mm hex 48 mm length, item# 00590103548, lot# 64797688. Hex headed screw 3. 5 mm hex 27 mm, item# 00590103527, lot# 64768589. Headless trocar drill pin 3. 2 mm diameter 75 mm length, item# 00590102000, lot# 65019755. The product has been 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 that a patient was revised approximately three months¿ post implantation due to subsidence. The tibia subsided and shifted medially. Patient stated he "felt something" while doing physical therapy rehab. Attempts to obtain additional information have been made; however, no more information is available.

 
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Brand NameNATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE E
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12287906
MDR Text Key265390514
Report Number0001822565-2021-02178
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173417
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42530007101
Device LOT Number64649464
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/30/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/04/2021
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: 08/06/2021 Patient Sequence Number: 1
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