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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 11/26/2017
Event Type  Death  
Manufacturer Narrative
(b)(4). Multiple mdr's were submitted for this event. Please see associated reports: 0001825034-2018-02744. (b)(6). Report source: literature. Borgwardt, arne, et al. ¿a randomized seven-year study on performance of the stemmed metal m2a-magnum and ceramic c2a-taper, and the resurfacing recap hip implants. ¿ the journal of arthroplasty, 2017, doi:10. 1016/j. Arth. 2017. 11. 061. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
 
Event Description
It was reported in a journal article, seven patients expired prior to 8 year follow-up. The timeframe between deaths and initial hip arthroplasty were not reported. The cause of death and relation to device are unknown. No further information has been provided at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. 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 as the necessary information to adequately investigate the reported event was not 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.
 
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Brand NameUNKNOWN CUP
Type of DevicePROSTHESIS, HIP
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 Key7434484
MDR Text Key105611069
Report Number0001825034-2018-02745
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/16/2018 Patient Sequence Number: 1
Treatment
UNKNOWN FEMORAL HEAD
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