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U.S. Department of Health and Human Services

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

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ZIMMER TMT UNKNOWN TM REVISION SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sepsis (2067)
Event Type  Injury  
Manufacturer Narrative
(b)(4). O'neill cj et al. Acetabular revision using trabecular metal augments for paprosky type 3 defects. The journal of arthroplasty 33. 2017: 823-828. No product, pictures, or medical records were provided for review. A review of the device history records was unable to be performed as the part and lot information was not provided. 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. Concomitant medical product(s): unknown tm augment. Report source: event occurred in (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 3005751028 - 2020 - 00041.
 
Event Description
It was reported from a journal article that in an unknown timeframe postoperatively, two patients developed recurrence of deep sepsis and required a 2-stage revision. No further information has been made available from this study.
 
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Brand NameUNKNOWN TM REVISION 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 Key9995807
MDR Text Key188934738
Report Number3005751028-2020-00042
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/09/2018
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

Patient Treatment Data
Date Received: 04/24/2020 Patient Sequence Number: 1
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