MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 DUAL MOBILITY LINER 42MM E; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000740, lot: 6500012, g7 neutral arcomxl lnr 36mm e, (b)(4); 010000740, lot: 6499982, g7 neutral arcomxl lnr 36mm e, (b)(4); 110024463, lot: 857940, g7 dual mobility liner 42mm e, (b)(4); 010000663, lot: 6549354 , g7 pps ltd acet shell 52e, (b)(4).Multiple mdrs were filed for this event.Please see associated: 0001825034 - 2019 - 03060, 0001825034 - 2019 - 03061, 0001825034 - 2019 - 03062.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 get three liners successfully impacted into the cup during surgery.The cup was removed and the surgery was completed without further issue with a new cup and liner.Surgery was delayed 30-45 minutes.No further information is available at the time of this reporting.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h2, h3, h6, h10.D4 ¿ udi # - (b)(4).D11 - medical products - unknown screw qty: (b)(4).Visual examination of the returned product identified: one g7 pps ltd acet shell 52e (6549354), two g7 neutral arcomxl lnr 36mm e (6500012) (6499982), one g7 dual mobility liner 42mm e (857940), and two unknown legacy zimmer screws were returned and evaluated.Upon visual inspection of the two arcomxl lnrs (6500012 and 6499982) the locking feature shows impact markings.The dual mobility liner shows damage to the post.There was no damage to the locking feature of the shell.Review of the device history record identified no deviations or anomalies during manufacturing.Root cause was unable to be determined.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 DUAL MOBILITY LINER 42MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8811741
• MDR Text Key: 151731703
• Report Number: 0001825034-2019-03063
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K150522
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110024463
• Device Lot Number: 857940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR