MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE PRIMARY STEM 12MM MICRO; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Joint Dislocation (2374)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog # lot # 113032 837990 versa-dial 42x18x46 hum head, cp0001156 076370 mini convertible e1 liner, 115395 413870 comp rvs cntrl 6.5x25mm st/rst, 118001 256620 versa-dial/comp ti std taper, 180552 651210 comp lk scr 3.5hex 4.75x25 st, 180553 571910 comp lk scr 3.5hex 4.75x30 st, 180556 723040 comp lk scr 3.5hex 4.75x45 st, pm0001410 676870 nerney lt pm mini conv glenoid, pm0001411 041070 nerney lt pm cnv accessory kit.Foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -08923.Patient retained implants.

Event Description

It was reported that a patient underwent a total shoulder arthroplasty.Subsequently, the patient was revised less than three (3) months post-implantation due to dislocation.No further information is available.

Manufacturer Narrative

Patient medical records and investigative inputs confirmed the reported malposition of the humeral stem which caused the patient dislocation.The surgeon confirmed the initial version of the humeral stem was incorrect which led to the recurrent dislocations.Dhr was reviewed and no discrepancies were found.Root cause is attributed to unintentional user error in primary device positioning.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 was reported the patient was revised to address chronic full and partial dislocation attributed to malposition of the humeral stem.No further information is available.

• Brand Name: COMPREHENSIVE PRIMARY STEM 12MM MICRO
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7906317
• MDR Text Key: 121610782
• Report Number: 0001825034-2018-08924
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113612
• Device Lot Number: 948300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention