MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BI-ANGULAR GLENOID; PROSTHESIS, SHOULDER

Catalog Number UNKNOWN BI-ANGULAR GLENOID

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Scar Tissue (2060); Muscle/Tendon Damage (4532)

Event Date 03/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date - unknown month and day in 2004.Concomitant medical products: unknown biangular stem cat#ni lot#ni.Unknown biangular head cat#ni lot#ni.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.

Event Description

It was reported that the patient underwent a total right shoulder replacement.Subsequently, the patient underwent a revision procedure approximately 11 years later due to a torn rotator cuff.The baseplate and glenoid were replaced with a custom baseplate and standard glenoid component.The torn rotator cuff was not related to a fault of the implants and the patient has a bone/joint disease.Medical records indicate that the patient presents with a history of pain with loosening of the glenoid component and massive rotator cuff insufficiency, failing to improve despite conservative care.The position of the bi-angular component was felt to be excellent.Further, there was abundant amounts of scar tissue and ectopic bone that was removed at the glenoid.A baseplate was placed with a large central screw and 4 peripheral screws utilizing a bone graft deep to the baseplate.Position and fit noted to be excellent.

Event Description

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

Manufacturer Narrative

Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: primary op records from initial surgery were not provided.Revision op records approximately 11 years later noted the patient presents with history of pain, glenoid loosening and rotator cuff insufficiency, along with scar tissue and ectopic bone.Post revision, patientdev was noted to have 135 forward flexion, 150 abduction, full internal and external rotation.No intraoperative complications.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined for the loose glenoid component.The rotator cuff deficiency remains related to patient's bone/joint disease.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 BI-ANGULAR GLENOID
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10744201
• MDR Text Key: 213384205
• Report Number: 0001825034-2020-03856
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN BI-ANGULAR GLENOID
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention