MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 32MM B; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

Patient Problem No Information (3190)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdrs were submitted for this event.Please see reports: 0001825034 - 2017 - 10652, report source: foreign.The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the surgeon could not successfully impact the acetabular liner into the acetabular cup after four attempts.The procedure was completed with another device(s) after a delay to surgery of 60 minutes.No further information has been made available at this time.

Manufacturer Narrative

Udi: (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The liner and cup were returned and evaluated.The liner assembled with the shell upon receipt but the fit was loose and would not fully seat.Scratches were found on the inside and outside of the elevated portion of the liner.Additional inspection of the liner found approximately half of the barb to be damaged.A small portion of the barb has become detached from the liner.No dimensional analysis will be performed due to the attempts to implant the liner.The shell was assembled with the liner upon receipt.The threads are damaged.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: G7 HI-WALL E1 LINER 32MM B
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7078190
• MDR Text Key: 93557404
• Report Number: 0001825034-2017-10651
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/05/2022
• Device Model Number: N/A
• Device Catalogue Number: 010000924
• Device Lot Number: 6142878
• Other Device ID Number: SEE NARATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 010000660 G7 PPS LTD ACET SHELL 46B LOT 6114923
• Patient Outcome(s): Hospitalization; Required Intervention