MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 58MM G; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A2: date of birth: information provided by the hospital showed the date of birth documented as two different dates: (b)(6) 1947 and (b)(6) 1948.D10: cat# 010000985 lot# 7648566 g7 freedom const e1 lnr 36mm g.Cat# 11-107021 lot# 884560 freedom constr hd 36mm t1 +9mm.Cat# 010000997 lot# 7681145 g7 screw 6.5mm x 20mm.Cat# 010000997 lot# 7641778 g7 screw 6.5mm x 20mm.Cat# 010000999 lot#7665793 g7 screw 6.5mm x 30mm.Cat# 010000999 lot# 7633835 g7 screw 6.5mm x 30mm.Cat# 010000999 lot# 7648566 g7 screw 6.5mm x 30mm.G2: foreign: country: australia.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.
Event or Problem Description
It was reported that the patient had a right total hip arthroplasty on an unknown date.The patient had a right hip revision approximately one month ago due to recurrent dislocations.Subsequently, the patient was revised approximately a weeks ago due to a pelvic fracture which led to cup loosening.It was reported that the pelvic fracture was thought to have occurred in the previous revision.No additional information available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6 no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The reported products, shell, liner, and screws were reviewed for compatibility with no issues noted.Medical records were not provided for the event related to the revision due to pelvic fracture leading to cup loosening.However, review of the available information by a health care professional identified the following: it was reported that patient had a right hip performed on an unknown date.Patient subsequently had a right hip revision due to recurrent dislocations and eccentric poly wear and was then revised a second time for recurrent dislocations.The patient experienced a pelvic fracture leading to cup loosening which resulted in an additional revision.Contributing factors to the bone fracture is unknown.The shell, liner and screws were explanted, and an unknown zimmer biomet stem was retained.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Unable to confirm complaint.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 OSSEOTI MULTIHOLE 58MM G
• Common Device Name: PROTHESIS, 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: 19097091
• Report Number: 0001825034-2024-01005
• Device Sequence Number: 7428827
• Product Code: LPH
• UDI-Device Identifier: 00887868356056
• UDI-Public: (01)00887868356056(17)340111(10)66390801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/31/2024

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: 110010267
• Device Lot Number: 66390801
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female