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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Insufficient Information (3190)
Patient Problems Pain (1994); No Information (3190)
Event Date 04/03/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr's were filed for this event. Please see associated report(s): 0001825034-2018-10348, 0001825034-2018-10350. Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. 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. Not returned to manufacturer.
 
Event Description
It was reported the patient underwent a metal-on-metal hip revision due to unknown reasons. No further information available.
 
Event Description
It was reported that a patient was revised approximately 15 years post implantation due to pain, elevated ion levels, metallosis, inflammation, and corrosion of the trunnion. Op notes indicated evidence of metal debris joint fluid, extensive corrosion of the trunnion, and evidence of superior acetabular erosion secondary to metal debris and inflammatory response. Attempts have been made, and no further information has been provided.
 
Manufacturer Narrative
This report is being submitted to relay additional information. Concomitant medical products: item # (b)(4), m2a 38mm mod hd , lot # unk; item # (b)(4), m2a 1 pc shell, lot # unk.
 
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Brand NameUNKNOWN STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8052578
MDR Text Key126596477
Report Number0001825034-2018-10349
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/08/2018 Patient Sequence Number: 1
Treatment
UNK PART/LOT HEAD, CUP; UNK PART/LOT HEAD, CUP
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