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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER STANDARD TAPER ADAPTOR; PROSTHESIS, SHOULDER

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BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER STANDARD TAPER ADAPTOR; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Weakness (2145)
Event Type  Injury  
Manufacturer Narrative
(b)(6).It is indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant devices ¿ comprehensive primary mini length shoulder stem catalog #: 113628 lot #: 646590, versa-dial shoulder modular head with variable offset catalog #: 113034 lot #: 360110, hybrid small 4mm glenoid base catalog #: 113952 lot #: 856280, pt hybrid regenerex porous glenoid post catalog #: pt-113950 lot #: 868290.This report is number 1 of 5 mdrs filed for the same patient (reference 0001825034-2017-03514 / 03516 / 03517 / 03518).
 
Event Description
It is reported that the patient underwent a right total shoulder arthroplasty.Subsequently, pain, impingement, and 2 mm of glenoid radiolucency were noted at six (6) week post-operative follow-up.The radiolucency reportedly resolved.Unusual pain, incision line tenderness, and weakness were noted at three (3) month post-operative follow-up.The pain reportedly persisted unchanged until the six (6) month post-operative follow-up.The patient was also prescribed additional physical therapy to treat the weakness.Glenoid radiolucency was again noted eleven (11) months post-operatively.Lastly, the patient experienced tenderness at the distal portion of the surgical incision two years following shoulder arthroplasty attributable to a keloid.The surgeon has no plans to revise or otherwise treat the patient, but the patient will continue to be monitored.No additional patient consequences have been reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies 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.
 
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Brand Name
COMPREHENSIVE SHOULDER STANDARD TAPER ADAPTOR
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6607759
MDR Text Key76516410
Report Number0001825034-2017-03515
Device Sequence Number1
Product Code MBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK060716
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/01/2017
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? No
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number118001
Device Lot Number625050
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/05/2017
Initial Date FDA Received06/02/2017
Supplement Dates Manufacturer Received07/31/2017
Supplement Dates FDA Received08/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2015
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) Other;
Patient Weight73
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