MAUDE Adverse Event Report: ZIMMER TMT TM GLENOID 52MM

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

Investigation in process.Remains implanted.

Event Description

It was reported that the patient had a tsa on (b)(6) 2011.Patient is reporting pain.Surgeon suspects early poly failure; infection work up negative; blood metal levels normal.Patient reluctant to have revision.

Manufacturer Narrative

It was reported that the patient experienced pain and that the surgeon suspected early poly failure.This investigation found that the tm glenoid was manufactured, inspected and packaged within established process specifications with no anomalies found.The mating humeral head was also found to be compatible with the tm glenoid that was implanted.The tm glenoid remains implanted (approximately 5 years, 5 months as of the date of the reported event) so its actual condition is unknown.However, an engineering review of the x-ray images that were provided (2 years, 6 months post-op) indicate an overall intact tm glenoid keel with an expected tm keel lateral edge profile, i.E., no damage is suspected in the area of the tm keel that is closest to the uhmwpe /humeral head interface.In addition, a simulated x-ray image derived from pristine cad models of each component in the shoulder construct was created and upon a visual comparison was found to appear essentially identical to the actual x-ray image, i.E., it is possible that the poly was entirely intact at 2 years, 6 months post-op.Ct scans at the time of the incident (5 years, 5 months post-op) were provided but the images were found to be distorted so an engineering assessment could not be made.This investigation by product development is considered closed at this time; however, should additional information become available, this investigation can be re-opened.

• Brand Name: TM GLENOID 52MM
• Type of Device: TM GLENOID
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 6137786
• MDR Text Key: 61204224
• Report Number: 3005751028-2016-00083
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00-4326-052-00
• Device Lot Number: 61718842
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2011
• 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): Required Intervention