MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED STD MITCH TRH CUP SIZE 44/50; HIP METAL ACETABULAR CUPS

Catalog Number MAC99884450

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).E3 initial reporter occupation: lawyer.No 510(k) number provided because this implant is sold internationally under a different product code; a similar device was sold in the us under a different part number.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Mitch email notification received as " legal personal injury claim notification from patient's lawyers.Loosening requiring revision in 2022.Mith tr system - ref mac-9988-445 + mfr -9988 -5044".

• Brand Name: STD MITCH TRH CUP SIZE 44/50
• Type of Device: HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business pk, randall; leatherhead, surrey
• Manufacturer (Section G): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park; randalls road; leatherhead, surrey
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18570999
• MDR Text Key: 333604970
• Report Number: 1818910-2024-01604
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MAC99884450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female