MAUDE Adverse Event Report: ZIMMER, INC. TRABECULAR METAL REVERSE SHOULDER GLENOSPHERE; SHOULDER PROSTHESIS

Catalog Number 00434904011

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, but not yet evaluated.

Event Description

It is reported the patient was revised due to disassociation following a shoulder arthroplasty.

Manufacturer Narrative

A 40mm glenosphere was returned for evaluation.As returned, scratches are seen on the buffed surface.The taper surface shows no defects or damage.Dimensional measurements are conforming to print specifications.Device history review indicates the devices were manufactured to specifications.Part and lot number of baseplate are unknown and hence device history review cannot be performed.This device is used for treatment.Initial product history search conducted on (b)(6) 2016 revealed no additional complaints against the related part and lot combination of the glenosphere.Baseplate part and lot number are unknown and hence product history search cannot be performed.Surgical notes were not provided.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.It is stated in the directions that one should "reconfirm uniform engagement between the base plate and glenosphere by using a small angled or 90 degree clamp to assess for malalignment gaps anterior to posterior, as well as inferior to superior." a definite root cause cannot be determined with the information provided.

Manufacturer Narrative

Udi # (b)(4).Root cause remains undetermined.

• Brand Name: TRABECULAR METAL REVERSE SHOULDER GLENOSPHERE
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5875912
• MDR Text Key: 52097863
• Report Number: 0001822565-2016-02799
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00434904011
• Device Lot Number: 63229508
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR