MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121146

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Ossification (1428); Injury (2348); No Code Available (3191)

Event Date 09/30/2019

Event Type  Injury  

Event Description

It was reported a revision surgery for unknown reasons.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the bhr head was removed.The 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 for the bhr cup.Similar complaints have been identified for the bhr head and this will continue to be monitored.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 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.According to the operative record the patient slipped and fell several months prior and had complaints of increasing pain.The reported pain along with intraoperative findings of femoral neck fracture are related to the patient¿s fall and is not 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.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.

Event Description

It was reported a revision surgery due to femoral neck fracture.

Manufacturer Narrative

It was reported that a 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 cup and head 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 bhr cup.Similar complaints have been identified for the bhr head and this failure will continue to be monitored.A 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 a result of the reported event.The available medical documents were reviewed.It cannot be determined to what extent the patient¿s previous fall had on his pain and clinical status.The reported pain, along with intraoperative findings of moderate heterotopic ossification, fluid within the joint and femoral neck fracture may be consistent with findings associated with a femur fracture and pseudotumor.However, without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported reactions cannot be confirmed, and it cannot be concluded that the 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.The root cause for the ¿heterotopic ossification¿ cannot be concluded as it can be genetically predisposed for some patients.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: RESURFACING FEMORAL HEAD 46MM
• 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: 9558641
• MDR Text Key: 173966366
• Report Number: 3005975929-2020-00007
• 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,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: 74121146
• Device Lot Number: 68862
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74120154 ACETLR CUP HAP 54MM W/ IMPTR 65940.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR