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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM; PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. COMPR SRS MOD STEM; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Tingling (2171); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 01/27/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 211254, compr srs 60mm dst hml bdy rt, 952960, 114817, disc ulna 3x115mm rt w/brng c, unknown, unknown, unknown discovery humeral condyle kit, unknown, 211270, compr srs large flange, 916200.Report source, foreign - the event occurred in the (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.X-rays were submitted to mmi for review.Overall fit and alignment of the implants is appropriate.There is likely osteopenia present.Radiolucency is noted along the ulnar component which is suggestive of loosening.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04151, 0001825034 - 2018 - 04152, 0001825034 - 2018 - 04153, 0001825034 - 2018 - 04154.Product location unknown.
 
Event Description
It was reported that the patient underwent right shoulder arthroplasty.During a one and three year follow up appointment, the patient experienced moderate to severe pain, difficulty sleeping, moderate tingling, difficulty opening a jar, difficulty doing heavy chores, difficulty carrying a bag, difficulty cutting, washing back, limited in social activities, and limited/ unable to do daily and recreational activities.Attempts have been made and additional information on the reported event is unavailable.
 
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Brand Name
COMPR SRS MOD STEM
Type of Device
PROSTHESIS, 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 Key7619084
MDR Text Key111670583
Report Number0001825034-2018-04150
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PK111746
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation Physician
Type of Report Initial
Report Date 06/20/2018
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? No
Device Operator Physician
Device Expiration Date11/11/2022
Device Model NumberN/A
Device Catalogue Number211236
Device Lot Number635430
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/27/2015
Initial Date FDA Received06/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2012
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 Age57 YR
Patient Weight54
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