MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED STD MITCH TRH CUP SIZE 48/54; HIP METAL ACETABULAR CUPS

Catalog Number MAC99884854

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

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).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

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination and no further evidence could be provided.Therefore, the reported event is not confirmed and cause could not be established.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: STD MITCH TRH CUP SIZE 48/54
• Type of Device: HIP METAL ACETABULAR CUPS
• 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: 16395843
• MDR Text Key: 309736789
• Report Number: 1818910-2023-03930
• Device Sequence Number: 1
• Product Code: LPH
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Catalogue Number: MAC99884854
• Device Lot Number: FM061643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/20/2023; 03/01/2023; 03/21/2023; 11/07/2023
• Supplement Dates FDA Received: 02/20/2023; 03/16/2023; 03/27/2023; 11/07/2023
• 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
• Treatment: ABG II FEMORAL STEM #7; MITCH TRH MD HD SZ 48+4