MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABLR CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120152

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Debris, Bone Shedding (1803); Toxicity (2333); Joint Dislocation (2374); No Code Available (3191)

Event Date 06/26/2018

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to instability, dislocations and metallosis.Further surgery for debridement of tissue debris (b)(6) 2018.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision the femoral head & acetabular cup were removed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the cup + 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 cup.Similar complaints have been identified for the head and this failure 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.Device history record review confirmed that all released parts met specifications applicable 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 medical documents were reviewed.The reported deformation of the femur secondary to the patient¿s previous subtrochanteric femur fracture as well as somewhat abnormal placement of the femoral rod causing bone to be in slightly abnormal position cannot be ruled out as a contributory factor to the reported instability and recurrent dislocations.The intraoperative findings of metal debris is consistent with findings associated with metallosis; however, without the supporting lab results, imaging, and the analysis of the explanted components, the root cause of the reported instability, recurrent dislocations, metallosis 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, follow-up debridement, 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: ACETABLR CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, CV313 HL; UK CV313HL
• MDR Report Key: 8036449
• MDR Text Key: 126064240
• Report Number: 3005975929-2018-00413
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 74120152
• Device Lot Number: 080224
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74121146 HEAD, LOT 81368.; BHR UNKNOWN DEVICE/ UNKNOWN LOT NUMBER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR