MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SEGMENTAL REVISION SYSTEM TUMOR BODY; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001825034-2018-02979.Concomitant medical products: patient matched implant custom reverse mini glenosphere constrained pncp0000739 ln708940.Foreign report source - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was not explanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial shoulder arthroplasty.Subsequently, the patient was revised two years later due to instability of the shoulder due to absence of deltoid muscles and implanted with a custom constrained shoulder.Furthermore, the patient underwent a revision three months later due to disassociation of the custom device from the proximal shoulder body.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.X-rays were received and reviewed.Per the review, "overall fit and alignment of the implants is appropriate.Patient is osteopenic.No signs of loosening, wear, radiolucency.The humeral stem does not appear to be attached to the humeral head/glenoid component.Device history record was reviewed and no discrepancies were found.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: COMPREHENSIVE SEGMENTAL REVISION SYSTEM TUMOR BODY
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7487986
• MDR Text Key: 107387851
• Report Number: 0001825034-2018-03026
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 211223
• Device Lot Number: 706860
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 80