MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METALA ACETABULAR REVISION SHELL; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Rheumatoid Arthritis (1724)
Date of Event	02/14/2020
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 was discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00662406560, bone screw self-tapping 60 mm length 6.5 mm dia., lot # 61458850, 00662406520, bone screw self-tapping 20 mm length 6.5 mm dia., lot # 63991418, 00662406525, bone screw self-tapping 25 mm length 6.5 mm dia., lot # 63896220, 00662406560, bone screw self-tapping 60 mm length 6.5 mm dia., lot # 62529457, 00662406550, bone screw self-tapping 50 mm length 6.5 mm dia., lot # 63991423, 00662406540, bone screw self-tapping 40 mm length 6.5 mm dia., lot # 63704581, 00662406540, bone screw self-tapping 40 mm length 6.5 mm dia., lot # 64080526.Report source: (b)(6).
Event or Problem Description
It was reported that approximately 17 months post implantation, the patient was revised due to loosening of the acetabular components.Attempts have been made and no further information has been provided.
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.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.A field action search using cognos bi identified no quality hold with an r-code as the reason associated with the following part/lot (00700006020/63767639) combination as of (b)(6) 2020.Radiographs were provided and reviewed by a health care professional through the linked complaint (b)(4).Review of the available records identified the following : loosened and displaced acetabular implant with fixation screw fractures.No further evaluation could be performed with the provided x-ray images.A definitive root cause cannot be determined.Additional associated devices: trabecular metal acetabular revision shell item# 00700006020 lot# 63767639 00662406560, bone screw self-tapping 60 mm length 6.5 mm dia., lot # 61458850.

• Brand Name: TRABECULAR METALA ACETABULAR REVISION SHELL
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9746274
• Report Number: 3005751028-2020-00013
• Device Sequence Number: 14115908
• Product Code: JDI
• UDI-Device Identifier: 00889024310896
• UDI-Public: (01)00889024310896
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K001759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00700006020
• Device Lot Number: 63767639
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR