MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 56F; PROSTHESIS, HIP

Model Number N/A

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Difficult or Delayed Separation (4044)

Patient Problem No Code Available (3191)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 163662 28mm mod head 753660.Xl-200150 act artic bearing 769510.110024464 g7 dual mobility liner unknown.192411 echo por fmrl stem 700340.Product has been received by zimmer biomet and 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 - 2020 - 02660 head.0001825034 - 2020 - 02663 bearing.0001825034 - 2020 - 02666 liner.

Event Description

It was reported patient underwent second right hip revision just over a month post initial implantation due to dislocation.During the procedure, disassociation of the dual mobility bearing was noted, head, bearing, liner, and shell components were removed and replaced.Disassociation possibly due to at home reduction attempt.Liner separation failure caused 120 min delay in the procedure.Cup came out during surgery while trying to remove duel mobility liner.New cup was cemented in place.No additional information is available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of radiographs.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Visual inspection found the liner to be assembled with the shell upon receipt.Scuffing and scratching was observed on the inner radius.The liner has been deformed and bent out of shape during attempts to remove the liner from the shell.No attempts to separate the devices were made in the lab.Radiographs indicate that there was a superior dislocation of a right tha.Cement fixation of the acetabular cup with prominent position of the acetabular cup because of a thick cement mantle.Possible fracture of the medial wall of the acetabulum.Heterotopic ossification along the greater trochanter was noted.Off label use could have contributed to the reported event.Porous acetabular shells and femoral stems are indicated for uncemented biological fixation.The implanted shell was found to be fixed in a cement mantle.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 PPS LTD ACET SHELL 56F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10244727
• MDR Text Key: 198094827
• Report Number: 0001825034-2020-02665
• Device Sequence Number: 1
• Product Code: PBI
• UDI-Device Identifier: 00880304524248
• UDI-Public: 00880304524248
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 010000665
• Device Lot Number: 6361060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 110024464 G7 LINER 373030; SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention