MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVSR SHLDR GLNSP +3 36MM; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 00434901613, humeral stem 16 mm stem diameter 130 mm stem, lot # 64448713.Catalog #: 00434906506, retentive poly liner, lot # 64333472.Catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr r, lot # 005110.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02726, 0001822565-2020-02727, and 0001822565-2020-02724.
Event or Problem Description
It was reported that the patient underwent a total shoulder procedure approximately 5 months ago.Subsequently the patient was revised one month later due to poly disassociation.Patient was revised again 3 months later due to disassociation and impingement.Wear on the interior of the stem and calcar was noted.Attempts have been made and there is no additional information available at this time.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed per review of the available x-rays which show the superior dislocation of the humeral component and now abutment of the glenosphere and the calcar with associated bony resorption.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVSR SHLDR GLNSP +3 36MM
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10384702
• Report Number: 0001825034-2020-03071
• Device Sequence Number: 14314383
• Product Code: KWS
• UDI-Device Identifier: 00880304475779
• UDI-Public: (01)00880304475779(17)291214(10)612700
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 115313
• Device Lot Number: 612700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention