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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN MULTI DIRECTIONAL SCREW PROSTHESIS, EXTREMITY

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ZIMMER BIOMET, INC. UNKNOWN MULTI DIRECTIONAL SCREW PROSTHESIS, EXTREMITY Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395)
Patient Problem Pain (1994)
Event Date 10/05/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. X rays were evaluated and the reported event was confirmed. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. X-ray review confirmed fracture of the distal radius; it was fixed with volar plate and screws, and has healed with malalignment of the distal fracture fragment. Position of the plate and orientation of the screws suggests malalignment of the distal radius likely occurred postoperatively, possibly due to lack of adequate fixation or other etiologies such as trauma. Lack of fracture fixation could possibly be due to too short of distal radius volar plate without adequate plating proximal to the fracture site. A distal ulnar arthroplasty prosthesis is also present, the head of which abuts the proximal cortex of the lunate. There is subchondral lucency of the proximal lunate, as well as diffuse sclerosis of the lunate. 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. 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.
 
Manufacturer Narrative
(b)(4). Multiple mdrs were submitted for this event. Please see reports: 0001825034 - 2017 - 09851. 0001825034 - 2017 - 09852. 0001825034 - 2017 - 09853. 0001825034 - 2017 - 09854. 0001825034 - 2017 - 09855. 0001825034 - 2017 - 09856. 0001825034 - 2017 - 09857. Concomitant products: dvr anatomic short right, unknown part/lot. Multi directional screw, unknown part/lot, qty: 2. Smooth peg, unknown part/lot, qty: 4. Ulnar component, unknown part/lot. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient was revised to address implant failure and pain. Because of the wrist collapsing, the ulnar implant leaned medially and worn into the bone causing wear/grooves into a couple of the pegs. No further information has been made available at this time.
 
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Brand NameUNKNOWN MULTI DIRECTIONAL SCREW
Type of DevicePROSTHESIS, EXTREMITY
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 Key6997095
MDR Text Key118005171
Report Number0001825034-2017-09852
Device Sequence Number1
Product Code JWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
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: 11/02/2017 Patient Sequence Number: 1
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