MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 FREEDOM CONST E1 LNR 36MM D; PROSTHESIS HIP

Catalog Number 010000982

Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed a follow-up mdr will be submitted (b)(6).

Event Description

It was reported that during a hip surgery surgeon implanted liner into cup, used regular force with hammer.Surgeon explained that the metal ring on liner slipped off in anterior and than completely off.Surgeon stated he had previously cleaned around cup, to make sure, there was not osteophytes and was also careful to insert the liners groves into the right emplacements into cup.Surgeon was aware of regular final placement of constrained liners.There was no other liners on site.Patient had to stay under anesthesia for 1hr 15min until another liner was retrieved from another hospital.Attempts have been made and additional information on the reported event is unavailable at this time.

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/corrected updated: d4, d9, g3; h2; h3; h4; h6.One g7 freedom const e1 lnr 36mm d item# 010000982 lot# 6760372 was returned and evaluated.Upon visual inspection the locking ring had some scuffing but no further damage.The liner had damage to the locking feature, indentations on the lip and on the outside radius of the device.There was also a cutout under the scallops.The dimensional analysis of the liner was conforming to specifications during manufacturing device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not 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 FREEDOM CONST E1 LNR 36MM D
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11787662
• MDR Text Key: 250667658
• Report Number: 0001825034-2021-01309
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000982
• Device Lot Number: 6760372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR