MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONSTRAINED LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: g7 osseoti multihole 64mm h, pn 110010270, ln 6459945.G7 freedom const e1 lnr 36mm h, pn010000986, ln6417235.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05252, 0001825034-2019-05254.Customer has indicated that the product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during total hip arthroplasty the cup was implanted and liner was impacted and would not stay in the cup.A second liner would not stay in the cup.The cup was removed and replaced with competitor product.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.Reported event was confirmed by review of one g7 osseoti multihole 64mm h, one g7 frdm const e1 10deg lnr 36h (373019), and one g7 freedom const e1 lnr 36mm h (6417235) was returned and evaluated.Upon visual inspection the shell shows scuffing from use.Both liners show damage to the locking feature.Liner with lot 3731019 has a scratch on the outside radius.Liner with lot 6417235 shows a circular indentation and some scratching on the outside radius.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 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 FREEDOM CONSTRAINED LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9368411
• MDR Text Key: 199119640
• Report Number: 0001825034-2019-05253
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K142882
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Model Number: N/A
• Device Catalogue Number: 110010285
• Device Lot Number: 3731019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• 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
• Patient Outcome(s): Required Intervention