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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT UNKNOWN SHELL PROSTHESIS, HIP

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ZIMMER TMT UNKNOWN SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Sepsis (2067)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical product: unknown femoral head; unknown acetabular liner; unknown femoral stem; unknown screw; unknown screw. Report source: literature - webb, j. E. Et al (2017). The double-cup construct: a novel treatment strategy for the management of paprosky iiia and iiib acetabular defects. The journal of arthroplasty, 32(9), 25-31. Doi: 10. 1016/j. Arth. 2017. 04. 017. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to 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
It was reported one patient experienced chronic uncontrollable deep infection required implant removal due to sepsis. No further information has been made available.
 
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Brand NameUNKNOWN SHELL
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 Key10000947
MDR Text Key191916109
Report Number3005751028-2020-00039
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/27/2020 Patient Sequence Number: 1
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