MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HI-WALL E1 LINER 40MM I; PROSTESIS, HIP

Catalog Number 010000945

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Joint Dislocation (2374)

Event Date 08/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the implant is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Udi: (b)(4).Concomitant medical products: part # 010000670 g7 shell lot # 6275966, part # 51-103220 tprlc 133 t1 pps so lot# 6143346, part # 650-1066 option taper sleeve lot# 2959127, part # 650-1058 bioloxd option hd lot# 2982812.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

It was reported patient underwent l hip closed reduction 1-month post implantation due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical notes stating patient bent over and fell on the floor causing hip to dislocate, patient underwent a closed reduction under general anesthesia.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to patient falling after leaning too fall forward as directed not to postop.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

It was reported that patient fell approximately 1 month post left hip procedure.The next day the patient underwent a closed reduction under general anesthesia.Attempts have been made and additional information is unavailable at this time.

• Brand Name: G7 HI-WALL E1 LINER 40MM I
• Type of Device: PROSTESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9163728
• MDR Text Key: 167817623
• Report Number: 0001825034-2019-04518
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

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: Health Professional
• Device Expiration Date: 04/25/2022
• Device Catalogue Number: 010000945
• Device Lot Number: 6046200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 98