MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 897620.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Will be returned.

Event Description

It has been reported that a patient underwent a shoulder arthroplasty approximately a month ago.Subsequently, the patient underwent a revision reverse total shoulder surgery about 2 weeks later due to glenosphere dissociation.

Event Description

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

Manufacturer Narrative

(b)(4).Updated: b4, b5, d10, g4, h1, h2, h3, h6, and h10.The taper adapter and glenosphere were returned for evaluation.The glenosphere was assembled to the taper adapter upon receipt.The baseplate was not returned.Visual inspection identified no major damages to the devices.Dimensional analysis of the taper were conforming to print specifications during manufacturing.Reported event was considered confirmed as x-rays showed dislocation of the glenosphere.Possible radiolucency or osteolysis was also seen surrounding the superior screw.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9859932
• MDR Text Key: 189431977
• Report Number: 0001825034-2020-01165
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465(17)291230(10)234780
• Combination Product (y/n): N
• PMA/PMN Number: K120121
• 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: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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: 010000589
• Device Lot Number: 234780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14 DA