MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SRS PROXIMAL BODY - SMALL SEGMENTAL REVISION SYSTEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: unknown humeral stem; unknown humeral bearing; unknown glenosphere; unknown glenoid baseplate.The complaint is in investigation, once the investigation is completed a follow up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09097, 0001825034 - 2018 - 09100, 0001825034 - 2018 - 09102, 0001825034 - 2018 - 09103.

Event Description

It was reported that patient underwent initial shoulder arthroplasty on unknown date, and a revision surgery has been indicated due to unknown reason.No additional information is made available.

Manufacturer Narrative

The follow up report is being submitted to relay additional information received concomitant medical products: unknown glenoid component.Unknown distal humeral component; unknown intra segmental assembly; cp0001010 mini reverse glenoid const 884050.A follow up report will be submitted once the investigation is completed.

Event Description

It was reported that patient underwent initial shoulder arthroplasty on unknown date, and a revision surgery has been indicated due to disassociation of the constrained head from the proximal humeral body.No additional information is made available.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of radiographs.Review of the x-rays demonstrated that the humeral head subcomponent had disassociated from the proximal humeral body.Review of device history records found these units were released to distribution with no related deviations or anomalies.Root cause could not be determined; however, the available documentation suggests "tension on the joint" may have been a contributing factor.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.

Event Description

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

Manufacturer Narrative

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.Udi #:(b)(4).Concomitant medical products: 211230, compr srs mod stem - 6x75mm, lot # 541500,  010000589, comp rvrs 25mm bsplt ha+adptr, lot # 161050.

• Brand Name: COMPREHENSIVE SRS PROXIMAL BODY - SMALL SEGMENTAL REVISION SYSTEM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7903080
• MDR Text Key: 121512379
• Report Number: 0001825034-2018-09098
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 211216
• Device Lot Number: 688930
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other