MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS 25MM BSPLT HA+ADPTR R; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported when the device packaging was opened it was missing the baseplate and as a result the patient had to be recut for a different size implant causing an unknown delay to surgery.No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

No further information is available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated, and the reported event was confirmed through physical evaluation.The returned product identified two (2) taper adapters instead of one (1) taper adapter and one (1) baseplate.The device history records were reviewed and no discrepancies were identified.The root cause was attributed to be a manufacturing deficiency.A corrective action was initiated to address this issue.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.

• Brand Name: COMP RVRS 25MM BSPLT HA+ADPTR R
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9265700
• MDR Text Key: 164599627
• Report Number: 0001825034-2019-04922
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00880304532465
• UDI-Public: (01)00880304532465
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• 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: 410420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2020
• 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