MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120154

Device Problem Fracture (1260)

Patient Problems Ossification (1428); Necrosis (1971); Osteolysis (2377)

Event Date 12/10/2007

Event Type  Injury  

Event Description

It was reported a left hip revision surgery due to avascular necrosis of the femoral head with a stress fracture of the femoral neck and sclerosis.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup 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 bhr head and 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.No further actions are required at this time.The available medical documents were reviewed.The reported pain, stress fracture of the lateral aspect of the femoral head with sclerosis on radiological exam, intraoperative findings of granular fluid within the acetabulum, along with collapse into the valgus of the femoral neck with osteolysis may be consistent with findings of heterotopic ossification and osteolysis.Without the supporting pathology results, imaging and/or the analysis of the explanted components the root cause of the reported pain and osteolysis cannot be confirmed and it cannot be concluded that these reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.In conclusion, based on the available information, the root cause for the ¿heterotopic ossification¿ cannot be concluded but some patients can be genetically predisposed it is a known complication of joint surgeries and is related to the procedure and not the device.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: ACETLR CUP HAP 54MM 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: 9659164
• MDR Text Key: 177356621
• Report Number: 3005975929-2020-00028
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• 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: 02/18/2020

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: 05/31/2012
• Device Model Number: 74120154
• Device Catalogue Number: 74120154
• Device Lot Number: 74909
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 74121146/ 076774; FEMORAL HEAD 74121146/ 076774
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR