MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED MITCH TRH MODULAR HEAD 48 +4 NECK; HIP METAL FEMORAL HEADS

Catalog Number MMH99881448

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Joint Dislocation (2374); Fibrosis (3167); Unspecified Tissue Injury (4559)

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).No 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.Product was marked for gudid exclusion.Unique identifier (udi) : udi/gtin information is not applicable.Product is no longer marketed.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported a revision was completed due to dislocation of the head.The large head consumed the morse taper of the stem causing dislocation of the head and necessitating the removal of the stem and reimplantation of a modular restoration with mdm.Mitch has not been cleared or approved for sale in the usa by the usfda, but similar products are sold in the usa.The mitch products will be reported as malfunctions for the noted dislocation.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, 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

Additional information received indicates that the histopathological findings of the joint fragment of left hip prosthetic loosening on (b)(6) 2023 reported fragment of fibro adipose and striated muscle tissue incorporating rare bone spicules with focal dystrophic calcifications, modest vascular proliferation, and focal necrosis.Presence, on board some fragments, of deposits of blackish pigment and modest histiocytic inflammatory infiltrate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.

Manufacturer Narrative

Mitch/asr international blurb: no 510(k) number provided because this implant is sold internationally with different indications for use; it was sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : mitch email notification received as "an abg stem implant with mitch, implanted over 11 years ago, has been revised.The large head consumed the morse taper of the stem causing dislocation of the head and necessitating the removal of the stem and reimplantation of a modular restoration with mdm".The mmh99881448 mitch trh modular head 48 +4 neck (lot number: fm072658) was returned to depuy synthes for evaluation as well as photos were provided for review.(b)(4).Review of the provided photos taken immediately post op shows an explanted mitch modular metal head with a competitor femoral stem.The mitch modular system is a legacy discontinued product line manufactured by finsbury orthopedics and distributed by stryker, whereas the femoral stem is a stryker competitor product.Both the head and the stem have a v40 taper and per the finsbury ifu appendix c rev.1, both devices are compatible.Per the images, the is no sign of a device failure with the mitch head, however the competitor stem taper appears to have fractured which would contribute to the disassociation event.No further analysis of the competitor stem will be conducted as it is not a depuy synthes device.Visual analysis of the returned device found no evidence of a product defect.A dimensional inspection would add no value to the investigation due to the used and worn condition of the head.Implant dislocation could not be confirmed from the provided photos, however, evidence of disassociation between the head and stem was found due to the competitor stem fracture.No defect with the mitch head was observed.No images of the mitch cup were provided.¿ based on the investigation findings, the cause is traced to competitor device failure and no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: MITCH TRH MODULAR HEAD 48 +4 NECK
• Type of Device: HIP METAL FEMORAL HEADS
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey ; UK
• Manufacturer (Section G): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park; randalls road; leatherhead, surrey ; UK
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16395818
• MDR Text Key: 309736415
• Report Number: 1818910-2023-03931
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2012
• Device Catalogue Number: MMH99881448
• Device Lot Number: FM072658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: ABG II FEMORAL STEM #7; STD MITCH TRH CP SZ 48/54