MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL¿¢ GLENOID COMPONENT 46 MM ARTICULAR SURFACE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Material Erosion (1214); Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Device remains implanted as per available information.Due to the litigation process, little detail is available to aid in this investigation at this time.A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

Event Description

Patient¿s legal counsel reported patient underwent right shoulder arthroplasty on (b)(6) 2012.Legal counsel further reports patient allegations of pain, loosening, loss of range of motion, metallosis and tissue damage.No revision has been reported yet.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.Tm glenoid is the only tmt design controlled part.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable as we do not have reporting responsibility for this complaint.The initial report was submitted in error and should be voided.

Event Description

It was reported through patient's legal counsel that approximately 4 year post implantation, the patient presented to their orthopedic doctor with pain and loss of range of motion.A ct scan revealed abnormal polyethylene wear, loosening of the glenoid from its metal back component, bone loss, and debris within the joint space.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).No product, images, or medical records were received for review.Review of the device history records did not identify any deviations or anomalies during manufacturing.A definitive 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.Concomitant medical product: 00434811213, humeral stem 48 degrees 12 mm stem diameter 130 mm stem length, lot 61905057.00430204627, offset modular humeral head 27 mm head height 46 mm spherical head diameter, 61977465.

• Brand Name: TRABECULAR METAL¿¢ GLENOID COMPONENT 46 MM ARTICULAR SURFACE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7488072
• MDR Text Key: 107390486
• Report Number: 3005751028-2018-00030
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2017
• Device Model Number: N/A
• Device Catalogue Number: 00432604600
• Device Lot Number: 61976949
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention