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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. UNKNOWN SCREW; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Implant date- approximately 4 years ago.Concomitant medical products: xl-115363, arcom xl 44-36 std hmrl brng, 588280, 115310, comp rvrs shldr glnsp std 36mm, 233870, unknown screw, unknown, unknown screw, unknown, unknown screw, unknown , unknown screw, unknown, 115370, comp rvs tray co 44mm, unk, 010000589, comp rvrs 25mm bsplt ha+adptr, 876360.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03130, , 0001825034-2019-03132, 0001825034-2019-03134, 0001825034-2019-03139, 0001825034-2019-03141.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product location unknown].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient's left shoulder was revised approximately 4 years ago due to glenosphere dissociation and screw loosening.No additional information available.
 
Manufacturer Narrative
(b)(4).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.Radiographs were reviewed however could not be assessed due to poor image quality.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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
UNKNOWN SCREW
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8819671
MDR Text Key152015838
Report Number0001825034-2019-03133
Device Sequence Number1
Product Code HSD
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,health profession
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight60
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