MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X40 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 11/29/2023

Event Type  Injury  

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 - 00303, 0002648920 - 2023 - 00304, 0002648920 - 2023 - 00305, 0002648920 - 2023 - 00306, 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.

Event 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 Description

No further information is available at the time of this report.

• Brand Name: BONE SCR 6.5X40 SELF-TAP
• Type of Device: 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: 18344633
• MDR Text Key: 330721090
• Report Number: 0002648920-2023-00307
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119840
• UDI-Public: (01)00889024119840(17)301201(10)J6916623
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00625006540
• Device Lot Number: J6916623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 98 KG