MAUDE Adverse Event Report: ZIMMER TMT TM GLENOID 40 X 46 ARTIC.; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330); Toxicity (2333); Joint Dislocation (2374); Reaction (2414)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

Device location unknown.

Event Description

It was reported that the patient had an initial left shoulder arthroplasty on (b)(6) 2004.Subsequently, the patient has been experiencing severe pain, discomfort, unstable grinding and very sore.X-rays showed dislocation and metalosis in the joint.Patient was revised in (b)(6) 2017 due to a failed glenoid component of the prosthesis.The anatomical side of the revision is unknown.Op reports reveal patient was revised due to implant fracture.

Manufacturer Narrative

Photographic and x-ray evidence as well as the revision operative report that was supplied with the complaint confirms that the tm glenoid (gen i) device had fractured at the junction between the keel and the baseplate.Noted is that the tm glenoid (gen1) has previously been voluntarily removed from the market since the implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement; therefore this investigation by product development is considered closed at this time; however, should additional information become available, this investigation can be re-opened.

Event Description

No additional information reported.

Manufacturer Narrative

Concomitant medical products: offset modular humeral head catalog 00430204621 lot 50274100.Modular humeral stem catalog 00430001413 lot 58679100.Revision operative notes demonstrated that the patient was revised due to pain, dislocation, and glenoid component fracture.During revision, metallosis was identified with intact capsular side of the rotator cuff.The stem was well fixed.The glenoid base had been sheared off.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TM GLENOID 40 X 46 ARTIC.
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7050943
• MDR Text Key: 92716916
• Report Number: 3005751028-2017-02734
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK022377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2008
• Device Model Number: N/A
• Device Catalogue Number: 00430604046
• Device Lot Number: 52632800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 86