MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 62MM H; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown head lot #: unknown.Item #: unknown stem lot #: unknown.010000938 g7 hi-wall e1 liner 36mm h 3929935.010000938 g7 hi-wall e1 liner 36mm h 6592108.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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: 0001825034-2019-05046 liner 1, 0001825034-2019-05047 liner 2.

Event Description

It was reported during an acetabular revision, a size 62 multihole osseoti cup was placed.Liner would not seat upon impaction.Liner was removed, cup was cleaned, screws were checked to ensure they were not proud.Tried this 4 more times and liner would not seat.Left hospital to go get a new liner.New liner would not seat.Surgeon commented it appeared to get hung up in same spot both times.There was no medial wall.Surgeon hit the liner hard but was cautious to hit too hard because of the suspect fixation and lack of medial support.Went to a dual mobility liner and it seated.Sixty minute delay, had to drive to different hospital to get a replacement liner.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Two g7 hi-wall e1 liner 36mm h were returned and evaluated.Upon visual inspection lot 3929935 shows circular indentations on the outside diameter along with shaving to the locking feature.Lot 6592108 shows shaving of the locking feature and damage to the scallop area.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: G7 OSSEOTI MULTIHOLE 62MM H
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9307364
• MDR Text Key: 184916739
• Report Number: 0001825034-2019-05082
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• 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: 110010269
• Device Lot Number: 6500439
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1