MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120148

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); Osteolysis (2377); Reaction (2414)

Event Date 10/12/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery from the right hip was performed due to progressive pain, popping, grinding, adverse metal reaction, severe osteolysis, large osteolytic lesion and pathologic fracture through the lesion in the posterior superior aspect of the acetabulum.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr cup and bhr head were removed.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 head / cup was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu 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.The reported intraoperative findings of loosening, osteolytic lesion may be consistent with findings associated with metal debris; however the reported fracture is likely a direct result of the patient¿s fall but since it¿s through the osteolytic lesion it cannot be ruled out to have contributed to the weakness in the bone.The root cause of the reported symptoms noted in the legal claim cannot be concluded and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient impact beyond the revision and expected post-operative healing/pain 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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETLR CUP HAP 48MM W/ IMPTR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 8310211
• MDR Text Key: 135160610
• Report Number: 3005975929-2019-00057
• 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: other
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 74120148
• Device Lot Number: 083678
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121142 RESURFACING FEMORAL HEAD 42MM L#078388; UNKNOWN BHR DEVICE/ UNKNOWN LOT; UNKNOWN BHR DEVICE/UNKNOWN LOT
• Patient Outcome(s): Hospitalization; Required Intervention