MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00434903603, poly liner plus 3 mm offset 36 mm diameter, 61615511, 00434901013, humeral stem 10 mm stem diameter 130 mm stem length, 61710194, 00434903909, humeral stem spacer size 9, 61781150, 00434903811, base plate uncemented, 61816059.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03523.Reported event was confirmed based on the information received from the customer, clinical reports.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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

It was reported that patient had initial right shoulder arthroplasty.Subsequently during the seven (7) years clinical visit the patient reports the shoulder feels like it slips out.It was reported as the patient experienced a total of three such occurrences prior to the visit.No interventions reported.Remains implanted.No additional information available.

Event Description

It was noted that the patient underwent a right primary ts.Subsequently, the patient was noted to have instability, pain, decrease function.No revision planned to date.The patient has completed eight (8) year follow-up and is continuing to have symptoms noted during the seven (7) year visit.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Reported event was confirmed by review of radiographs and medical records.Review of the available records identified the following: onset (b)(6) 2018: the patient will be monitored.Pt follow-up in the clinic for evaluation when able.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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: GLENOSPHERE 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8916342
• MDR Text Key: 155065529
• Report Number: 0001822565-2019-03524
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K191814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2020

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00434903611
• Device Lot Number: 61811540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 04/10/2020
• Supplement Dates FDA Received: 11/05/2019; 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 58