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

Catalog Number 00432604600

Device Problem Material Erosion (1214)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that a patient underwent an initial right shoulder arthroplasty.Approximately six years post implantation, the patient began experiencing severe pain.Bloodwork has shown elevated metal ions and diagnostic x-ray images show unspecified issues with the implanted prostheses.No additional medical intervention has been reported and the current outcome of the patient is unknown.The products remain implanted.

Manufacturer Narrative

(b)(4).The onset of pain occurred in 2021, though exact date is unknown.Medical product: tm humeral stem 48deg 11mm x 130mm: catalog#00434811113, lot#62860168; bf offset humeral head 18mm x 46mm: catalog#00430204618, lot#62816975.The product will not be returned to zimmer biomet for evaluation, as the product remains implanted.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  no product was returned.No photograps were avavialable.Visual and dimensional evaluations could not be performed.The device history records were reviewed for deviations and/or anomalies with no related anomalies/deviations identified.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for the reported part and lot combination.Medical records were not provided.The complaint is not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• 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
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16060887
• MDR Text Key: 306284113
• Report Number: 3005751028-2022-00023
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 00432604600
• Device Lot Number: 62854867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Sex: Female