MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Foreign Body In Patient (2687)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat# 650-1057 lot# 2958832 cer bioloxd option hd 36mm.Cat# 650-1065 lot# 2959085 cer option type 1 tpr sleve -3.Cat# 00625006530 lot# 64403729 bone scr 6.5x30 self-tap.Cat# 010000856 lot# 6443904 g7 neutral e1 liner 36mm d.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent an initial left total hip arthroplasty that was subsequently revised approximately four (4) years later due to pain, noise, instability, osteolysis, and loosening.During the revision while placing the cage noted a screw broke and was unable to retrieve broken part.The stem was well fixed and remained implanted.The shell, liner, head, and taper sleeve were exchanged without complications.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: x-ray found acetabular loosening superomedial breaching medial wall, ct ¿ osteolysis, acetabular protusio consistent with loosening, nondisplaced fracture of inferior medial wall, acetabular component malposition.Pain in left hip for 15 months along with clicking, instability, snapping/popping, no history of falls in last 12 months, ambulating with assistive device.Noted acetabular bone loss superior and medial.No complications, noted procedure 100% took more time due to large acetabular bone defect, need for cage and additional fixation.A definitive root cause cannot be determined.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.

• Brand Name: G7 PPS LTD ACET SHELL 50D
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16643144
• Report Number: 0001825034-2023-00705
• Device Sequence Number: 5491143
• Product Code: PBI
• UDI-Device Identifier: 00880304524217
• UDI-Public: (01)00880304524217(17)290522(10)6549335
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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 Model Number: N/A
• Device Catalogue Number: 010000662
• Device Lot Number: 6549335
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 81 KG