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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BASEPLATE; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. UNKNOWN BASEPLATE; PROSTHESIS, SHOULDER Back to Search Results
Catalog Number UNKNOWN
Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 05/28/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical devices: cat: unknown taper lot: unknown; cat: 115310 lot: 160140 comp rvrs shldr glnsp std 36mm; cat: 00434903603 lot: 64596739 poly liner plus 3 mm offset 36 mm diameter.Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 01850.
 
Event Description
It was reported that the glenosphere taper did not engage properly into the baseplate and disassociated as a result.The patient underwent a revision procedure four days post initial surgery to correct the event.Possible soft tissue impingement.No additional patient consequences were reported.
 
Manufacturer Narrative
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.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 additional event information is available at the time of this report.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that the baseplate and taper are packaged together and hence only one subform is required.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that the baseplate and taper are packaged together and hence only one subform is required.The initial report was forwarded in error and should be voided.
 
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Brand Name
UNKNOWN BASEPLATE
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key12049338
MDR Text Key257721226
Report Number0001825034-2021-01851
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SEE NARRATIVE IN H10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
Patient Weight82
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