MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI 4 HOLE SHELL 54MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown head lot #: unknown.Item #: unknown stem lot #: unknown.010000850 g7 neutral e1 liner 32 mm f 3841534.010000850 g7 neutral e1 liner 32 mm f 6074805.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03757 liner 1.0001825034 - 2019 - 03758 liner 2.

Event Description

It was reported that two g7 e1 liners would not assemble with g7 acetabular shell.Surgery was finished with backup product.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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 report 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: G7 OSSEOTI 4 HOLE SHELL 54MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8932900
• MDR Text Key: 160522550
• Report Number: 0001825034-2019-03760
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010245
• Device Lot Number: 6416552
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1