MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 14MM MINI; PROSTHESIS, EXTREMITIES

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: item# 118001; versa-dial/comp ti std taper; lot# 349060.Item# 110031424; cr vivacit-e 36mm brng std; lot# 64343846.Item# 110031402; mini tray std cocr +3 offset; lot# 64327562.Item# 115310; comp rvrs shldr glnsp std 36mm; lot# 664970.Item# 115395; comp rvs cntrl 6.5x25mm st/rst; lot# 139000.Item# 180558; comp nlk scr 3.5hex 4.75x20 st; lot# 236640.Item# 180552; comp lk scr 3.5hex 4.75x25 st; lot# 795520.Item# 180551; comp lk scr 3.5hex 4.75x20 st; lot# 641130.Item# 115330; comp rvrs shdr glen bsplt +ha; lot# 760180.Foreign: event happened in (b)(6).The reported event was confirmed by a review of x-rays.A review of the available records identified separation of the glenosphere from the base plate of the reverse-type right shoulder arthroplasty.Device history record was reviewed and no discrepancies were found.The root cause was unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05661, 0001825034-2019-05662.
Event or Problem Description
It was reported patient suffered pain due to disassociated prosthesis approximately one month post-implantation.Due to short notice, replacement implants and instruments were not available.The surgeon reattached the glenosphere and humeral bearing to baseplate, used 2 juggerknots to help stabilize the shoulder.Two cerclage wires were attached to site.The comprehensive stem had fractured.Patient will be observed to see how he does.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: COMP PRIMARY STEM 14MM MINI
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10137813
• Report Number: 0001825034-2020-01839
• Device Sequence Number: 2318436
• Product Code: HSD
• UDI-Device Identifier: 00880304449732
• UDI-Public: (01)00880304449732
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 113634
• Device Lot Number: 300540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 06/10/2020
• 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