MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 60MM G; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a pmi product for an unknown reason.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign: south africa.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: a2, a3, a4, b3, b5, b7, g3, g6, h2, h6 no product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.Unable to confirm complaint.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
It was reported that the patient was born with hip dysplasia.The patients cup started to wear and was revised.The patient fell one year post implantation and it was found that the patient's cup was loose.It was recommended the patient wait for a custom implant.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D10: 010001003 g7 screw 6.5mm x 50mm 6468223.010001000 g7 screw 6.5mm x 35mm 7073501.010000998 g7 screw 6.5mm x 25mm 6847824.11-301241 arcos cal sz a std +20 60mm 768840.00-2232-001-18 1.8mm stainless steel cable 65223148.00-2232-001-18 1.8mm stainless steel cable 65202341.00-4894-054-10 acet augm size 54.10mm thick 64803382.00-4199-001-38 acet restrictor 38mm dia 64583137.11-300615 arcos 15x200mm prx tpr dist 363960.110024465 g7 dual mobility liner 46mm g 357930.Ep-200152 act artic e1 hip brg 28x46mm 348730.650-1067 cer option type 1 tpr sleve +3 3087988.650-1055 cer bioloxd option hd 28mm 3087109.281001100 ball nose guide wire 100cm 165570.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02828; 0001825034 - 2023 - 02829; 0001825034 - 2023 - 02830.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: impressions: progressive osteolysis along both the femoral and acetabular implants of the left hip arthroplasty as noted with loosening and vertical malrotation of the acetabular implant.A definitive root cause cannot be determined.The event is confirmed via xray.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 additional event information to report at this time.

• Brand Name: G7 OSSEOTI MULTIHOLE 60MM G
• Common Device Name: PROTHESIS, HIPS
• 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: 17861926
• Report Number: 0001825034-2023-02296
• Device Sequence Number: 5929907
• Product Code: LPH
• UDI-Device Identifier: 00887868356063
• UDI-Public: (01)00887868356063(17)310510(10)7024727
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/18/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110010268
• Device Lot Number: 7024727
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 11/10/2023; 01/17/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/06/2023; 12/01/2023; 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 78 KG