MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROSTHESIS, HIP

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Material Erosion (1214)

Patient Problems Pain (1994); Synovitis (2094); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).010000858 lot 3464309 g7 liner, 010000998 lot 3369624 screw, 650-1057 lot 638180 biolox head, 650-1065 lot 714270 taper adaptor.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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: 0001825034-2022-00940.

Event Description

It was reported that the patient underwent an initial right total hip arthroplasty.The patient was revised approximately 5 years post implantation due to pain, elevated metal ions and component migration.The acetabular cup, modular head and taper adapter were removed and replaced and a polyethylene liner was implanted.Subsequently, the patient underwent a second revision approximately 2 years post first revision due to pain, component loosening, failure to osseointegrate, and metallosis.The shell, liner, taper adapter, and head were exchanged without complications.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.The following sections were updated/corrected updated: d4; h2; h3; h4; h6 medical records were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues of continued pain, loose cup that was easily removed without removal of the screws, no bony ingrowth.Rom and stability good, no complications.Pathology report reported inflammation, synovitis, and metallosis.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 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 54F
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14164505
• MDR Text Key: 289725984
• Report Number: 0001825034-2022-00941
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304524231
• UDI-Public: (01)00880304524231(10)3509221(17)250224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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 Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 3509221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female