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

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	04/05/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Common Device Name: 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
• Report Number: 0001825034-2022-00941
• Device Sequence Number: 5908725
• Product Code: LPH
• UDI-Device Identifier: 00880304524231
• UDI-Public: (01)00880304524231(10)3509221(17)250224
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female