MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 50 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 Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately two years after a second stage revision due to acetabular loosening.The head, shell, liner, and augment were replaced.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: cat# 11-363662, lot# 531590, 36mm cocr mod hd std.Cat# 00630505036, lot# 64389201, liner standard 3.5 mm offset 36 mm.Cat# 00489405010, lot# 64578579, 50mm x 10mm thickness acetabular augment.G2: foreign ¿ australia multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 03613, 0002648920 - 2023 - 00304, 0002648920 - 2023 - 00305, 0002648920 - 2023 - 00306, 0002648920 - 2023 - 00307, 0002648920 - 2023 - 00308, 0002648920 - 2023 - 00309.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records identified the following: an initial right tha was performed with unknown implants.A second stage revision occurred two years later due to infection and zimmer products were implanted.A revision occurred two years later due to the acetabular component loosening.The shell, liner, screws, augment, and femoral head were explanted and replaced with unknown devices.Radiographs identified the following: loosening and slight displacement of the right hip arthroplasty acetabular implant with screw fractures noted.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records and the mmi report confirming the reported event of shell loosening and screw fracture.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 information is available at the time of this report.

• Brand Name: BONE SCREW SELF-TAPPING 50 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18344608
• Report Number: 0002648920-2023-00303
• Device Sequence Number: 5380671
• Product Code: JDI
• UDI-Device Identifier: 00889024127692
• UDI-Public: (01)00889024127692(17)260731(10)63401093
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K840643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00662406550
• Device Lot Number: 63401093
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 98 KG