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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 46 MM O.D. PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. SHELL 46 MM O.D. PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Pain (1994)
Event Date 10/15/2015
Event Type  Death  
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required as no trends were identified. 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 that the patient experienced pain after receiving a zimmer versys hip replacement system. The patient had a fitmore hip stem. It was later reported that the patient died post-implantation from unrelated complications.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required as no trends were identified. 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 that the patient experienced pain after receiving a zimmer versys hip replacement system. The patient had a fitmore hip stem. It was later reported that the patient died post-implantation from unrelated complications.
 
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Brand NameSHELL 46 MM O.D.
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6289266
MDR Text Key66137093
Report Number0002648920-2017-00040
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK833991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00500104600
Device Lot Number62738211
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 Received11/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2014
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: 01/31/2017 Patient Sequence Number: 1
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