MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs 110010267 g7 osseoti multihole 58mm g lot# 7084562; mdr: 0001825034-2022-00232.
Event or Problem Description
It was reported that the patient had a total hip arthroplasty.The patient was non-compliant (due to the patient not following restrictions at rehab) and the cup, augment block, and screws loosened.Therefore, the patient was revised with a bigger cup, bigger augment, and screws approximately 1-2 months later.Subsequently, the patient was non-compliant again, therefore will be revised again in the near future with a custom trifflange.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.No product was returned; visual and dimensional evaluations could not be performed.Scanned and electronic device history records for were reviewed for deviations and/ or anomalies.Records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause of the reported issue is attributed to the patient being non-compliant to post operative care as reported by the surgeon.Per ifu/package insert under the important notes section 'zimmer biomet is not liable for complications arising from the use of the device outside of its indicated uses, surgical technique or judgment, product selection, and similar matters outside the control of zimmer biomet.Complications and/or failure of prosthetic implants are more likely to occur in patients with unrealistic functional expectations, heavy patients, physically active patients, and/or with patients who fail to follow through with the required rehabilitation program.Physical activity can result in loosening, wear, and/or fracture of the implant.The prospective implant patient must be counseled about the capabilities of the implant and the impact it will have on his or her lifestyle.¿ no corrective actions, preventive actions, or field actions resulted after investigation of this event.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 further event information available at the time of this report.

• Brand Name: TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: chrsitina arnt ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 13479282
• Report Number: 3005751028-2022-00001
• Device Sequence Number: 5211435
• Product Code: LPH
• UDI-Device Identifier: 00889024306783
• UDI-Public: (01)00889024306783(17)250531(10)64634283
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K042871
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00489405020
• Device Lot Number: 64634283
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2020
• 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
• 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 Sex: Female