MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHDR GLEN BSPLT; PROSTHESIS, EXTREMITY

Catalog Number 115330

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2019 - 02456, 0001825034 - 2019 - 02457, 0001825034 - 2019 - 02458, 0001825034 - 2019 - 02459, 0001825034 - 2019 - 02460.Concomitant medical products: 115330, lot: 410400 comp rvrs shdr glen 28mm bsplt +ha, (b)(4); 180550, lot: 540630 comp lk scr 3.5hex 4.75x15 st (b)(4); 115396, lot: 479990, comp rvs cntrl 6.5x30mm st/rst, (b)(4); 180550, lot: 432280, comp lk scr 3.5hex 4.75x15 st, (b)(4); 180550, lot: 540690, comp lk scr 3.5hex 4.75x15 st, (b)(4); 180551, lot: 372480, comp lk scr 3.5hex 4.75x20 st, (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported the patient fell causing the patient glenoid to fracture and the construct to pull away.No further information available at this time.

Event Description

No further information available at this time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned for evaluation.Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.Medical records were not provided.However, it was reported the patient fell causing the patient glenoid to fracture and the construct to pull away.The root cause of the reported issue is attributed to human factor issue.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.

• Brand Name: COMP RVRS SHDR GLEN BSPLT
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8712998
• MDR Text Key: 148452471
• Report Number: 0001825034-2019-02461
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115330
• Device Lot Number: 410400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR