MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Concomitant medical products: 118001, versa-dial/comp ti std taper, 297720.115330, biomod/comp rev base std, 436740.118001, versa-dial/comp ti std taper, 297700.11-113706, bio-mod st.10x115 w/align hole, 936090.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-07590, 0001825034-2017-07591, 0001825034-2017-07592.

Event Description

It was reported a patient underwent shoulder revision approximately six years post-implantation due to pain, dysfunction, aseptic loosening, elevated metal ion levels, and adverse local tissue reaction.During the revision, the glenosphere and baseplate were found to be loose.Extensive wear on trunnion was noted, which is suspected to be the source of the metallosis and metal ion elevation.All components were revised.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device was not involved in the event.The initial report was submitted in error and should be voided.

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6904768
• MDR Text Key: 87791250
• Report Number: 0001825034-2017-07589
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 593670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR