MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE; PROSTHESIS, SHOULDER

Catalog Number 115313

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Swelling (2091); Synovitis (2094); Tissue Damage (2104)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Procode: phx.Udi: (b)(4).Concomitant medical products: comp primary stem 7mm mini cat#113627 lot#520260, comp lk scr 3.5hex 4.75x25 st cat#180552 lot#364330, comp lk scr 3.5hex 4.75x30 st cat#180553 lot#438850, comp lk scr 3.5hex 4.75x35 st cat#180554 lot#098090, comp lk scr 3.5hex 4.75x35 st cat#180554 lot#436520, comp rvs cntrl 6.5x35mm st/rst cat#115397 lot#194940, versa-dial taper adaptor 25mm cat#110031378 lot#797700, compr vrs glen pps min tpr adr cat#110027734 lot#797660.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 00282, 0001825034 - 2020 - 00283, 0001825034 - 2020 - 00284, 0001825034 - 2019 - 05658, 0001825034 - 2020 - 00287, 0001825034 - 2019 - 05659, 0001825034 - 2020 - 00286, 0001825034 - 2020 - 00288.

Event Description

It was reported the patient underwent implantation of a right reverse total shoulder revision following treatment for periprosthetic infection with cement spacer implantation.The patient was progressing well until one year postoperatively when the patient began experiencing pain.Radiology findings revealed fractured screws with dislodged components within the joint in addition to tendon tears, osteolysis, and synovitis.Subsequently, the patient underwent a revision, but no further information was provided.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: office visit 2 weeks postop - intraoperative cultures were unexpectedly positive.Infectious disease consulted, minimal pain, no fever, continuing antibiotics, incision healing well, continue home exercises.No complaint made for positive intraop cultures as patient was recovering from recently diagnosed periprosthetic infection.Patient showed no sign of infection in the joint, negative frozen sections and pathology reports, no postop fever, redness, incision complications, or other sign of infectious process.Revision implants remained in place for greater than 1 year without plan for additional intervention.Cultures were likely contaminated by environment or residual bacteria from previous infection.Office visit 6 weeks postop - pain well controlled, incision well-healed, there is weakness in external rotation and elevation as would be expected, x-ray review demonstrates appropriate alignment, continue long-term antibiotics and pt office visit 1 year postop - x-ray review demonstrates no changes and stable, continue exercises and antibiotics.Approximately 17 months post-op: mri findings - dislocated glenosphere and metaglene from a reverse total shoulder with failure of fixation in the glenoid and markedly diminished bone stock within the glenoid.There is a moderate synovitis but without features typical of active infection.Subscapularis tendon is torn and scarred to the anterior capsule, and both the infraspinatus and supraspinatus tendons are torn and attached to ununited bony fragments.Ct findings - interval fracturing of screws affixing the metaglene to the glenoid such that the metaglene and glenosphere have been dislodged and are now loose, floating together in the glenohumeral joint.There is also a loose screw posterior to the proximal aspect of the humeral component.There is prominent osteolysis about the proximal aspect of the humeral component, suggestive of loosening of the humeral component.X-ray findings - same as ct/mri plus the residual glenoid is markedly remodeled.Per maude report: patient states rtsa was removed 2019, no further medical records provided for explantation review.Review of the device history record(s) identified no deviations or anomalies during manufacturing of lot# 100770 related to the reported event.Contributing factors of event: extensive history of tsa, subsequent periprosthetic infection, tsa removal with intraop humeral fracture, antibiotic spacer placement, antibiotic infusions a definitive root cause cannot be determined.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 is available at the time of this report.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9631407
• MDR Text Key: 177360870
• Report Number: 0001825034-2020-00285
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115313
• Device Lot Number: 100770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 77