MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN TRABECULAR METAL HUMERAL STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Synovitis (2094)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned [as it was kept by the hospital] to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-02192 and 0001822565-2017-02194.

Event Description

It was reported that the patient underwent a left shoulder revision due to pain.During the revision, both metallosis and synovitis were noted as well as wear to the poly with fracturing.All components were removed and cement spacers were implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of provided photographs.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.It is stated in revision op-notes that "the superior rotator cuff had been essentially torn and retracted" and "the glenoid component demonstrated complete loss of the central aspect of the poly-component with fracturing of the thinnest part of the poly.The poly was also delaminated from the trabecular metal." root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN TRABECULAR METAL HUMERAL STEM
• Type of Device: PROSTHESIS, SHOULDER
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6485413
• MDR Text Key: 72535268
• Report Number: 0001822565-2017-02194
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

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: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR