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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 10X100MM PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 10X100MM PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Ambulation Difficulties (2544)
Event Date 03/18/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 211226, compr srs ic seg - 90mm, 067980; 211250, compr srs 50mm dst hml bdy lt, 155910; unknown, unknown discovery humeral condyle kit, unknown; cp562016, disc lt seg ulna 5x115mm, 50332. 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 on most images. No obvious evidence for wear. Lucency is seen along the humeral component consistent with loosening. Dhr was reviewed and no discrepancies were found. Root cause could not be determined with information available. Lucency suggestive of loosening can be a contributing factor to the adl difficulty. 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's were reported for this event. Please also see associated events: 0001825034 - 2018 - 01697; 0001825034 - 2018 - 01699; 0001825034 - 2018 - 04243; 0001825034 - 2018 - 04244. Product location unknown.
 
Event Description
It was reported that the patient reported being unable to do the following; open a jar, heavy chores, recreational activities, carry a bag, and wash back which limited daily activities. Subsequently, the patient was revised due to loosening and/or implant migration. No further information has been made available at this time.
 
Manufacturer Narrative
(b)(4). This follow-up report is being submitted to relay additional information.
 
Event Description
It was reported that the patient underwent a left elbow surgery. As part of the study, the patient underwent a left elbow revision procedure. Subsequently, during a six month and one year follow up appointment, the patient reported being unable to do the following; open a jar, heavy chores, recreational activities, carry a bag, and wash back which limited daily activities. Subsequently, the patient was revised due to loosening and/or implant migration. No further information has been made available at this time.
 
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Brand NameCOMPR SRS MOD STEM - 10X100MM
Type of DevicePROSTHESIS, ELBOW
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 Key7633649
MDR Text Key112163752
Report Number0001825034-2018-01698
Device Sequence Number1
Product Code JDC
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
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number211237
Device Lot Number753020
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2012
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 Treatment Data
Date Received: 06/25/2018 Patient Sequence Number: 1
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