MAUDE Adverse Event Report: ZIMMER TMT TM GLENOID COMPONENT 52 MM ARTICULAR SURFACE

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Remains implanted.

Event Description

It was reported patient underwent right shoulder arthroplasty on (b)(6) 2014.Subsequently patient is experiencing tightness around humeral head, looseness around humeral stem.Limited range of motion, numbness, always in some degree of pain.Went to other doctor and he said humeral head too tight and ball of the shoulder too big.Bone scan was inconclusive.Tm glenoid is the only tmt design controlled part.

Manufacturer Narrative

No x-rays or photos were received; therefore the condition of the device is unknown.A review of the implant's manufacturing record indicates that it was manufactured to specification.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.X-rays were not provided.Requests were conducted through zimmer biomet warsaw complaint 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.Remains implanted.

• Brand Name: TM GLENOID COMPONENT 52 MM ARTICULAR SURFACE
• Type of Device: TM GLENOID
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7239090
• MDR Text Key: 98967650
• Report Number: 3005751028-2018-00017
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00432605200
• Device Lot Number: 62724270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 62 YR