MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 OSSEOTI MULTIHOLE 56MM F; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05200, 0001825034-2017-05199, 0001825034-2017-05198.Concomitant medical products - taperloc porous stem pn: 11-103204 ln: 615600, m2a-magnum modular head pn: 157444 ln: 352790, m2a-magnum taper body pn: 139254 ln: 338140.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.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 a patient is scheduled for a right hip revision approximately 12 years post-implantation due to unknown reasons.No revision has been reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Review of the complaint history determined that no further action(s) is/are required.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05201 0001825034-2017-05200, 0001825034-2017-05199, 0001825034-2017-05198.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Op notes state that patient is considered for a revision due to aseptic failure revision right tha.During the procedure inspection of components found well fixed and in good condition, but there was an acute local tissue reaction.Although the reaction was mild it provided for instability of the hip.There was no corrosion but the taperloc stem was cold-welded.New shell, liner, head and screws were placed.No other complications were noted during the procedure.Patient was shifted to recovery room in stable condition.The additional information does not change the outcome of the previous investigation.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 56MM 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6746407
• Report Number: 0001825034-2017-05201
• Device Sequence Number: 19236207
• Product Code: KWA
• UDI-Device Identifier: 00880304544413
• UDI-Public: (01)00880304544413(17)260831(10)3863836
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2022

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: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 110010266
• Device Lot Number: 3863836
• 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
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 12/01/2017; 07/14/2022
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 12/01/2017; 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• 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 Sex: Female
• Patient Weight: 66 KG