MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) HEMI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122550

Device Problems Compatibility Problem (2960); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)

Event Date 11/20/2019

Event Type  Injury  

Event Description

It was reported that, after a bhr-tha construct had been implanted in a tha surgery, the patient experienced severe pain, limited mobility, extensive metallosis, and pseudotumor.A revision surgery was performed on the patient as a result of the premature failure of the devices.The femoral head and cup were replaced.The patient outcome is unknown.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that on (b)(6) 2020 with the confirmation of the operative records, it was noticed that the patient femoral head explanted was from striker, therefore non a s&n component, with the current information it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed.During the revision, the head, sleeve and cup were removed.The stem remained implanted.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.A review of the complaint history for the acetabular cup, hemi head and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the cup.Similar complaints have been identified for the head and sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of the product's instructions for use found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event.The available medical documents were reviewed.Without the supporting lab/pathology results and/or imaging, the root cause of the pseudotumor and metallosis cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.However, the patient¿s possible mismatched stryker head and stryker sleeve adaptor cannot be ruled out as a contributing factor to the patient¿s pseudotumor and metallosis.The reported metallosis could be related only to the stryker metal on metal bearing and not the smith and nephew components.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.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, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10439218
• MDR Text Key: 203980971
• Report Number: 3005975929-2020-00305
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2013
• Device Catalogue Number: 74122550
• Device Lot Number: 08HW18252
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/17/2020; 02/26/2021
• Supplement Dates FDA Received: 08/24/2020; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BHMH SLEEVED MODULAR
• Patient Outcome(s): Hospitalization; Required Intervention