MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 13MM MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 09/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: ep-115393, e1 44-36 std hmrl brng, 769470; 115310, comp rvrs shldr glnsp std 36mm, 607900; 010000589, comp rvrs 25mm bsplt ha+adptr, 683150; 115370, comp rvs tray co 44mm, 417300; 180552, comp lk scr 3.5hex 4.75x25 st, 047960; 115397, comp rvs cntrl 6.5x35mm st/rst, 261750; 180550, comp lk scr 3.5hex 4.75x15 st, 492460; 180550, comp lk scr 3.5hex 4.75x15 st, 135290; 180553, comp lk scr 3.5hex 4.75x30 st, 870160.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034 - 2018 - 02475, 0001825034 - 2018 - 02476.

Event Description

It was reported a patient underwent left hip revision due pain, disassociation of glenosphere and baseplate, and stem loosening.All components were revised.No further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes.Dhr was reviewed and no discrepancies were found.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.Not returned to manufacturer.

• Brand Name: COMP PRIMARY STEM 13MM MINI
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7414737
• MDR Text Key: 105143785
• Report Number: 0001825034-2018-02478
• 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: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/23/2015
• Device Model Number: N/A
• Device Catalogue Number: 113633
• Device Lot Number: 932850
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2018
• 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
• Patient Age: 59 YR