MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 32 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL; PROSTHETIC, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

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

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00875304801, shell with cluster holes porous 48 mm o.D.Size gg for use with gg liners, 63716493.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03546.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.

Event Description

It was reported that during the left total hip arthroplasty, after implanting the shell, the liner couldn't be seated in the shell.Subsequently the surgeon completed the surgery with a different shell and liner.Delay of 40 minutes was noted.Attempts have been made and additional information on the reported event is unavailable.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Damage in the form of gouges and scratched along the elevated rim of the liner and on the inner radius of the liner were noted.Nicks and scratches were noted on the shell near the elevated portion of the liner.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.

• Brand Name: LINER ELEVATED RIM 32 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7664522
• MDR Text Key: 113251941
• Report Number: 0001822565-2018-03545
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK151448
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00875200832
• Device Lot Number: 63746657
• Other Device ID Number: (01) 00889024149670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 48