MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/04/2015

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to elevated cobalt and chromium levels and tissue inflammation.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to elevated cobalt and chromium levels and tissue inflammation.During revision, the bhr cup and the bhr head were removed.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records for the bhr cup were reviewed.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Review of manufacturing records for bhr head was performed.Review of the records indicated the device was an acceptable product when released and met specifications applicable at the time of production.However, the full supporting documentation for the casting goods inwards inspection was not available.The missing documentation has been addressed through a non-conformance report and root cause analysis was performed on this documentation non-conformance.The available medical documents were reviewed.Various factors can increase the risk for dislocation, such as extreme movements, impingement between bony or implant structures, a suboptimal implant position or insufficient soft tissue tension.According to the provided implant report, it was reamed up to 56 mm and a 56 mm outer diameter cup was placed.According to the surgical technique (lit.No 10/10 rev a 4567-0103), it should be reamed to 1 to 3 mm smaller than the cup size.It cannot be excluded that this had an effect on the primary stability and consequently on the implant position.According to the provided revision report, the patient dislocated the hip the first time 6 months before the revision (1 year and 3 months after implantation), when leaning over an edge and lifting something.This was managed non-operatively.2 months before the revision, the hip dislocated again when rising from the toilet.During the revision a tannish membrane layer was noted that was consistent with persistent exposure of synovial fluid and maybe adverse reaction to metal.It was noted that the hip had dislocated posteriorly and the cup had maybe not enough anteversion.A relation of the reported possible adverse reaction to metal with the recurrent dislocations and reduction manoeuvre cannot be excluded as these might have caused damage to the articulating surfaces.Whether in fact the cup position contributed to the dislocation can also not be further investigated.Additionally, other factors can increase the risk for dislocation, such as extreme movements, impingement between bony or implant structures or insufficient soft tissue tension.Information to support the complaints report of elevated metal ion levels were not provided for inclusion in this investigation so it cannot be confirmed if it was present.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 56MM 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: 7517749
• MDR Text Key: 108355848
• Report Number: 3005975929-2018-00167
• 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
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 74120156
• Device Lot Number: 12JW13189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 50MM 74121150 LOT 13LW14463; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention