MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01102110

Device Problem Corroded (1131)

Patient Problem Metal Related Pathology (4530)

Event Date 10/31/2018

Event Type  Injury  

Event Description

On the literature article named "modular junction may be more problematic than bearing wear in metal-on-metal total hip arthroplasty", it was reported that, after a smf stem had been implanted on 4 patients, 4 revision surgeries were performed due to adverse reaction to metal debris.During these surgeries, blackened corroded debris was observed at the junction between the stem and the modular neck.All stems were well fixed and required an extended femoral osteotomy for their removal.The bearings were changed to ceramic on ceramic.

Manufacturer Narrative

H3, h6: it was reported within the literature article "modular junction may be more problematic than bearing wear in metal-on-metal total hip arthroplasty", that revision surgeries were performed due to adverse reactions to metal debris.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.The devices would have met manufacturing specifications at the time of production.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all the attached images.Therefore, no further interpretation of the attached images is required.No further medical assessment is warranted at this time.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 11819671
• MDR Text Key: 250450852
• Report Number: 3005975929-2021-00235
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01102110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MO
• Patient Outcome(s): Required Intervention