MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL ARCOMXL LNR 32MM F; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Subluxation (4525)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of birth: 1955.Concomitant medical products: 192008 ¿ echo stem ¿ 234540.010000664 ¿ g7 shell ¿ 3347010.Report source: denmark.The product will not be returned to zimmer biomet for the investigation as the product remains implanted.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 -02451.
Event or Problem Description
It was reported that patient experienced a subluxation with non-surgical repositioning approximately 12 days post implantation.Subsequently, the patient experienced a second subluxation with a lifting task approximately 6 years later and a third subluxation approximately 8 months later.Non-surgical repositioning was performed after both episodes of subluxation.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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: luxation after bending forward to tie shoes.Closed repositioning resolved incident.Resolved without complications.No revision has been reported and all implants remain in place.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.
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 information.
Event or Problem Description
It was reported that the patient underwent a revision procedure 8 years post implantation due to recurrent dislocation and subluxation.The cup, head and liner were all exchanged and the stem remains implanted.There is no additional information available at the time of this report.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, g3, g6, h2, h6, h11.A review of complaint history identified additional similar complaints for the reported items and part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: findings: luxation while bending forward to perform a lifting task.Closed repositioning resolved incident.Luxation after bending forward to tie shoes.Closed repositioning resolved incident.Luxation after bending over; dislocation/subluxation which resulted in a closed reduction revision.Revision due to dislocation, retained stem a definitive root cause cannot be determined.The event is confirmed.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 NEUTRAL ARCOMXL LNR 32MM F
• 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: 15704244
• Report Number: 0001825034-2022-02452
• Device Sequence Number: 20066688
• Product Code: PBI
• UDI-Device Identifier: 00880304524910
• UDI-Public: (01)00880304524910(17)200826(10)3634912
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2024

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 Expiration Date: 08/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000733
• Device Lot Number: 3634912
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 04/26/2024; 09/25/2024
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/05/2022; 05/20/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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: Other
• Patient Sex: Female
• Patient Weight: 62 KG