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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIO MODULAR HUMERAL STEM; POSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. BIO MODULAR HUMERAL STEM; POSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4).It is unknown which stem is implanted in the right shoulder.Lot# 214910 or 051420, sterile date: mar 31, 2011 or oct 31, 2012.Imp date: (b)(6) 2002 or (b)(6) 2002.Mfg date: mar 9, 2001 or oct 25, 2002.Medical product: bio-mod glenoid, catalog#: 113870, lot#: 690580 or 001000; bio-mod hum head, catalog#: 113760, lot#: 796750 or 961790; bio-mod centering sleeve, catalog#: 113789, lot#: 924610.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.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
It was reported that the patient had an initial right shoulder arthroplasty.Subsequently, the patient has been indicated for a revision due to loosening of implant.Constrained, custom shoulder components have been requested for revision.
 
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Brand Name
BIO MODULAR HUMERAL STEM
Type of Device
POSTHESIS, SHOULDER
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 Key7279706
MDR Text Key100405631
Report Number0001825034-2018-00671
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK030710
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number11-113700
Device Lot NumberSEE H10
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/25/2018
Initial Date FDA Received02/19/2018
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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