MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 40 MM LENGTH 6.5 MM DIA.; 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 devices: 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 # 64080526; 00700006020, trabecular metalac acetabular revision shell, lot # 63767639.Report source: event occurred in the (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00106, 0002648920 - 2020 - 00107, 0002648920 - 2020 - 00108, 0002648920 - 2020 - 00109, 0002648920 - 2020 - 00110, 0002648920 - 2020 - 00112.
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.The following sections were update/corrected updated: b4, b5, g4, g7, h2, h3, h6.The reported event was able to be confirmed by review of medical records.Provided radiographs were reviewed by a hcp and identified loosened and displaced acetabular implant with fixation screw fractures.No further evaluation could be performed with the provided x-ray images.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause was unable to 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.

• Brand Name: BONE SCREW SELF-TAPPING 40 MM LENGTH 6.5 MM DIA.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9746230
• Report Number: 0002648920-2020-00111
• Device Sequence Number: 14115910
• Product Code: JDI
• UDI-Device Identifier: 00889024127685
• UDI-Public: (01)00889024127685
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K840643
• 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): 06/23/2020

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 Model Number: N/A
• Device Catalogue Number: 00662406540
• Device Lot Number: 63704581
• 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: 06/18/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention