MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 9MM MINI; EXTREMITIES, IMPLANT

Model Number N/A

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

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 115370, lot# 265090, comp rvs tray co 44mm.Item# xl-115366, lot# 976430, acrom xl 44-41 std hmrl brng.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.Discarded.

Event Description

It was reported that the patient underwent a revision of the humeral stem due to loosening.

Event Description

It was reported patient was revised approximately two years post-implantation due to loosening and pain post revision patient was complaining of 10/10 pain due to a fall while changing a tire.The spare fell onto his left shoulder and pinned both arms.Bone scan of the left upper extremities showed increased uptake in the mid diaphysis and along the humeral prosthesis suggesting loosening humeral component.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi# (b)(4).Reported event was confirmed by review of medical records.Device history record 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.

• Brand Name: COMP PRIMARY STEM 9MM MINI
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8728925
• MDR Text Key: 149058269
• Report Number: 0001825034-2019-02712
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113629
• Device Lot Number: 075090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 65