MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 ACETABULAR SHELL; PROSTHESIS, HIP

Catalog Number 010000661

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #51-107110, taperloc complete micro femoral stem, lot #6283007; item #010000847, g7 acetabular liner, lot #628387; item #650-1056, biolox delta ceramic head, lot #2898741; item #650-1066, taper adapter, lot #2922739.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03590.

Event Description

It was reported that bilateral patient underwent right total hip arthroplasty.Subsequently, approximately two and a half months post op the patient began experiencing pain.The patient is scheduled to have a revision surgery due to pain and implant loosening.However, no revision procedure has been reported to date.Additional information was requested, however none was available.

Event Description

Upon reassessment of the reported event, the cup was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon reassessment of the reported event, the cup was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: G7 ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8915957
• MDR Text Key: 155054899
• Report Number: 0001825034-2019-03589
• 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: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 010000661
• Device Lot Number: 6289131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 77