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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM PRIMARY REVISION LENGTH SHOULDER STEM; PROSTHESIS, SHOULDER

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BIOMET ORTHOPEDICS COMPREHENSIVE SHOULDER SYSTEM PRIMARY REVISION LENGTH SHOULDER STEM; PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Noise, Audible (3273)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 09/07/2017
Event Type  Injury  
Manufacturer Narrative
Cmp- (b)(4).Customer has not indicated whether the product will be returned to zimmer biomet for investigation.Product still remains implanted at this time.Once the investigation has been completed, a follow-up mdr will be submitted.Medical products-comprehensive reverse tray catalog#:115370 lot#:488700; comprehensive primary stem catalog#:113668 lot#:044560; central screw catalog#:115396 lot#:402710; locking screw catalog#:180551 lot#:369350; locking screw catalog#:180553 lot#:651160; non-locking screw catalog#: 180558 lot#:030300; non-locking screw.Catalog#:180557 lot#:030260; comprehensive glenosphere catalog#:115310 lot#:383280; humeral bearing catalog#:ep-115393 lot#:864620; steinmann pin catalog#:405800 lot#:572700; drill catalog#:405883 lot#:797890; bone cement catalog#:402433 lot#:003990; hip kit catalog#:417000 lot#:608885; dia drill catalog#:405889 lot#:958000.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-02912, 0001825034-2017-02926, 0001825034-2017-02913, 0001825034-2017-02931, 0001825034-2017-02884, 0001825034-2017-03047, 0001825034-2017-03048, 0001825034-2017-03049, 0001825034-2017-03050, 0001825034-2017-03053, 0001825034-2017-03052, 0001825034-2017-03051, 0001825034-2017-01739.
 
Event Description
It is reported the patient underwent a reverse shoulder arthroplasty.Subsequently, approximately two (2) years post-operatively, the patient experienced a loud pop in the shoulder and pain.Subsequent radiographs revealed a peri-prosthetic fracture and indications that the humeral tray may be loosening or disconnecting from the humeral stem.No revision procedure has been reported to date.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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
It is reported the patient underwent a reverse shoulder arthroplasty.Subsequently, approximately two (2) years post-operatively, the patient experienced a loud pop in the shoulder and pain.Subsequent radiographs revealed a peri-prosthetic fracture and indications that the humeral tray may be loosening or disconnecting from the humeral stem.Patient was later revised to a custom reverse shoulder transplant.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required x-ray review impressions: earlier x-rays show right shoulder hemi-resurfacing arthroplasty with loosening of the humeral component and superior subluxation of the humerus indicative of superior rotator cuff deficiency.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 SYSTEM PRIMARY REVISION LENGTH SHOULDER STEM
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 Key6569188
MDR Text Key75248008
Report Number0001825034-2017-03302
Device Sequence Number1
Product Code MBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK060692
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 12/12/2017
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? Yes
Device Operator Physician
Device Expiration Date07/31/2019
Device Model NumberN/A
Device Catalogue Number113668
Device Lot Number044560
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/20/2017
Initial Date FDA Received05/16/2017
Supplement Dates Manufacturer Received09/15/2017
12/12/2017
Supplement Dates FDA Received10/11/2017
12/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2009
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
Treatment
REFERENCE H10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age25 YR
Patient Weight57
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