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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RADIAL STEM PROSTHESIS, WRIST

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ZIMMER BIOMET, INC. RADIAL STEM PROSTHESIS, WRIST Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Swelling (2091)
Event Date 11/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Concomitant medical products: part # unk, radial body, lot # unk. Part # unk, carpal plate, lot # unk. Part # unk, capitate stem, lot # unk. Part # unk, carpal head, lot # unk. Part # unk, radial screw, lot # unk. Part # unk, ulnar screw, lot # unk. Event occurred in (b)(6). Multiple mdr reports were filed for this event; please see associated reports: 0001825034-2018-11304, 0001825034-2018-11305, 0001825034-2018-11307, 0001825034-2018-11308, 0001825034-2018-11309, 0001825034-2018-11310.
 
Event Description
It was reported that approximately 8 years post implantation, the patient had reports of swelling and pain to the wrist. During the first-stage revision, the surgeon had discovered loosening, migration and fracturing of the screws, and local "metalosis". Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Reported event was confirmed by review of x-rays and photographs. The porous part of the radial stem showed some bone growth. The radial body is worn possibly due to loosened carpal head. Damage on back of radial body possibly happened during explantation. X-rays reviewed showed suggestion of loosening of the radial component and eventual subsidence of the carpal component. Backing out of the ulnar screw also seen as a result. Device history records could not be reviewed as lot number is unknown. A definite root cause cannot be determined with the information 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.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameRADIAL STEM
Type of DevicePROSTHESIS, WRIST
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8184142
MDR Text Key130994358
Report Number0001825034-2018-11306
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
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 Received01/03/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
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