MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(b)(4).Concomitant medical products: item number: 110017124, item name: g7 finned hole shell, lot #: 6330870, item number: unknown, item name: unknown head, lot #: unknown, item number: unknown, item name: unknown stem, lot #: unknown.Foreign report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03675.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the acetabular liner would not assemble with the acetabular shell due to the liner fitting loosely into the shell.Another liner was used to complete the case.Attempts have been made and no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection found the liner to be damaged consistent with the attempts to seat the liner.The majority of the barb has been roughed and deformed.Which is consistent with the locking feature of the poly liner sitting in the locking feature of the cup.A poly strand protrudes from the barb in one location.Multiple surface scratches are present on the outer radius of the liner with one large scratch.Two circular indentations were also observed in the outer radius.These indentations take on the pattern of the screw holes of the corresponding shell.Note there is a large dimple where the liner aligns with the apical hole of the acetabular shell.It is undetermined how the dimple was formed but appears to have been caused during the removal of the liner from the shell.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 NEUTRAL E1 LINER 36MM F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8917817
• MDR Text Key: 195176697
• Report Number: 0001825034-2019-03674
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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 Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000858
• Device Lot Number: 6395274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1