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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 18 MM HEIGHT 52 MM DIAMETER; PROSTHESIS, SHOULDER
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ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 18 MM HEIGHT 52 MM DIAMETER; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problems Pain (1994); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671)
Event Date 08/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 00430204652 glenoid component pegged 52 mm diameter articular surface used with white (46 mm) instruments 62890682, 00434211313 humeral stem 42 degrees 13 mm stem diameter 130 mm stem length 62357351.The complaint is under investigation.Once the investigation is complete a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01265, 0001822565 - 2019 - 01266.
 
Event Description
It was reported that the patient underwent an initial left shoulder arthroplasty.The patient began experiencing limited range of motion/strength, a grinding sensation, and increased pain in the shoulder shortly following the initial procedure.The patient was subsequently revised approximately seventeen (17) months post primary implantation due to pain, tendon tear and lucency.No additional information is available.
 
Manufacturer Narrative
The complaint is under investigation.Once the investigation is complete a follow up report will be submitted.
 
Event Description
It was reported that the patient underwent an initial left shoulder arthroplasty.The patient began experiencing limited range of motion/strength, a grinding sensation, and increased pain in the shoulder shortly following the initial procedure.The patient was subsequently revised approximately seventeen (17) months post primary implantation due to pain, tendon tear and instability.No additional information is available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Review of the device history record(s) identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).Medical records were provided and review of the available records identified the following: no intraoperative complications noted during initial surgery and "significant scarring of the subacromial space with the subscap and deltoid adhered to the proximal humerus¿small full-thickness supraspinatus tendon tear.Minimal bone loss proximal humerus.Posterior rotator cuff was intact." was noted on revision op-notes.Reported event was confirmed by review of medical records.A definitive root cause cannot be determined.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
OFFSET MODULAR HUMERAL HEAD 18 MM HEIGHT 52 MM DIAMETER
Type of Device
PROSTHESIS, SHOULDER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8478342
MDR Text Key140767956
Report Number0001822565-2019-01268
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K103404
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00430205218
Device Lot Number63081908
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
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