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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT UNKNOWN TRABECULAR METAL ACETABULAR AUGMENT PROSTHESIS, HIP

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ZIMMER TMT UNKNOWN TRABECULAR METAL ACETABULAR AUGMENT PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Erosion (1750)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Mäkinen, t. J. , abolghasemian, m. , watts, e. Fichman, s. G. , kuzyk, p. Safir, o. A. & gross, a. E. (1 may 2017) management of massive acetabular bone defects in revision arthroplasty of the hip using a reconstruction cage and porous metal augment. The bone & joint journal, vol. 99-b, no. 5, pages 607-613. Https://doi. Org/10. 1302/0301-620x. 99b5. Bjj-2014-0264. R3. Concomitant medical products: unknown acetabular cage, catalog #: ni, lot #: ni. The product could not be evaluated and the reported event was not confirmed. The device history records could not be reviewed as the lot number associated with the reported event is unknown. A definitive root cause could not be determined with the information provided. 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. This complaint has been reassessed as part of ca-(b)(4). It was determined that additional regulatory reporting is required. [management of massic acetabular bone defects. Pdf].
 
Event Description
It is reported that the patient underwent a vascular graft and resection arthroplasty to treat ischial flange erosion into the external iliac artery post-operatively. Attempts have been made and no additional information is available.
 
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Brand NameUNKNOWN TRABECULAR METAL ACETABULAR AUGMENT
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer (Section G)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer Contact
william hara
10 pomeroy road
parsippany, NJ 07054
9735760032
MDR Report Key9986238
MDR Text Key191371746
Report Number3005751028-2020-00018
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
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 Received09/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/22/2020 Patient Sequence Number: 1
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