MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE 30 MM POST LENGTH +2 MM LATERAL OFFSET UNCEMENTED; EXTREMITIES, IMPLANT

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 00434900817; lot# unk; humeral stem 8 mm stem diameter 170 mm stem length.Item# 00434903611; lot# unk; glenosphere 36 mm diameter.Item# 00434903600; lot# unk; poly liner plus 0 mm offset 36 mm diameter.Item# 0104223030; lot# unk; anatomical shoulder reverse, screw system, 4.5-30.Item# 0104223048; lot# unk; anatomical shoulder reverse, screw system, 4.5-48.Item# 47430902501; lot# unk; pin 2.5 mm diameter (2).Item# 47430904601; lot# unk; drill 2.5 mm diameter.Report source: foreign: event occurred in (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent left shoulder arthroplasty.Subsequently, the patient is being considered for a revision due to loosening of the tm reverse baseplate.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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 available at the time of this report.

• Brand Name: BASE PLATE 30 MM POST LENGTH +2 MM LATERAL OFFSET UNCEMENTED
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10576426
• MDR Text Key: 208291146
• Report Number: 0001822565-2020-03325
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K130661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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: 00434903002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 67 YR