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

Model Number N/A

Device Problem Torn Material (3024)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

It was reported that a patient underwent an initial shoulder procedure on (b)(6) 2012.Subsequently, the patient was revised due to rotator cuff tear on (b)(6) 2017.Revised to reverse tsa due to full thickness rotator cuff tear.The subject was revised using a biomet comprehensive reverse shoulder implant.Tm glenoid is the only tmt design controlled part.

Manufacturer Narrative

The tm glenoid is not alleged to have failed nor has this engineering investigation uncovered any failure; rather the patient was revised due to a right shoulder rotator cuff tear with instability.Per the operative report, a ¿well-fixed glenoid component¿ was identified during the revision surgery where it was required to be sliced into pieces using an osteotome and burr for removal.Additionally, an engineering review of the x-ray images shows what appears to be a single radiopaque particle of unknown origin at a location inferior to the tm glenoid keel in the images reported as 12, 24 and 36 months post-op.The radiopaque particle location appears to have remained fixed throughout this 24 month period.The radiopaque particle was not seen in the images reported as 6 weeks and 6 months post-op.This investigation by product development is considered closed at this time; however, if additional information becomes available, this investigation can be re-opened.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Review of the patient's medical records identified that during the revision, a well-fixed glenoid component was identified.The patient was revised due to a right rotator cuff tear with instability.Review of the device history records identified no deviations or anomalies during manufacturing.The reported event was not caused by the device.Root cause was determined to be patient condition.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.

Event Description

No further event information available at the time of this report.

• 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: 7258713
• MDR Text Key: 99597724
• Report Number: 3005751028-2018-00016
• 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: study
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00432605200
• Device Lot Number: 62051918
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 01/19/2018; 04/24/2020
• Supplement Dates FDA Received: 05/01/2018; 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 164