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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER; PROSTHESIS, SHOULDER

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ZIMMER BIOMET, INC. TM REVERSE POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Unintended System Motion (1430)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 01/04/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 00434901013, humeral stem 10 mm stem diameter 130 mm stem length, 6279079.2 00434903611, glenosphere 36 mm diameter, 62989469.00434901500, base plate 15 mm post length uncemented, 63035360.The complaint is under investigation.Once the investigation is complete a follow mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06719, 0001822565 - 2018 - 06725, 0001822565 - 2018 - 06727.
 
Event Description
It was reported in a clinical study that the patient underwent initial left reverse shoulder arthroplasty and was subsequently experiencing ongoing pain, impingement at one and two year time frame follow-ups.Limited range of motion and worsening pain were noted at three year time frame follow-up.No medical intervention was required.No additional information is available at this time.
 
Manufacturer Narrative
The complaint was confirmed based on the clinical documents.Device history records were reviewed and no deviations and/ or anomalies were found.A definite root cause cannot be determined with the information 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 information is available to report at this time.
 
Manufacturer Narrative
The follow report is submitted to relay additional information received: foreign- (b)(6).The complaint is under investigation.Once the investigation is completed a follow up report will be submitted.
 
Event Description
No additional information is available to report at this time.
 
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Brand Name
TM REVERSE POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8135635
MDR Text Key129432920
Report Number0001822565-2018-06722
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
PMA/PMN Number
K052906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/08/2019
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 Health Professional
Device Expiration Date01/31/2023
Device Model NumberN/A
Device Catalogue Number00434903600
Device Lot Number62890669
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/12/2018
Initial Date FDA Received12/05/2018
Supplement Dates Manufacturer Received12/06/2018
03/01/2019
Supplement Dates FDA Received01/02/2019
03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight70
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