MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 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	Pain (1994); No Code Available (3191); Subluxation (4525)
Date of Event	11/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 8 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.¿ this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00110 / 00111).
Event or Problem Description
It was reported that patient underwent right total hip arthroplasty on (b)(6) 2015.Subsequently, patient underwent non-surgical repositioning on (b)(6) 2015 due to luxation.No further information has been provided.
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.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
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: patient underwent a non-surgical repositioning performed requiring one day hospitalization and later had groin pain following repositioning.Musculoskeletal/connective tissue not captured as this is not an unexpected finding as the patient increases activity no change in root cause the event is confirmed via medical records.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): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5359948
• Report Number: 0001825034-2016-00111
• Device Sequence Number: 16202066
• 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: PK121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date (Section B): 09/27/2024

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?: No
• Operator of Device: Physician
• Device Expiration Date: 08/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000733
• Device Lot Number: 3634912
• Other Device ID Number: N/A
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/26/2024; 09/25/2024
• Initial Report FDA Received Date: 01/12/2016
• Supplement Report FDA Received Date: 05/21/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 62 KG