MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 58MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120158

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Physical Resistance/Sticking (4012)

Patient Problems Toxicity (2333); Injury (2348)

Event Date 08/23/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery of the right hip was performed due to elevated metal ion levels, clicking, stiffness and other symptoms.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.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 hemi head, cup and sleeve 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 hemi head.Similar complaints have been identified for the cup and sleeve 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.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.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.Per the surgical technique, the acetabular component is to be impacted with 15-20° of anteversion and 40-45° inclination angle.However, the implantation operative report indicated the acetabular component was implanted at 25° anteversion.It is unknown if the increased anteversion of the acetabular component led to accelerated wear and the corrosion and discolored fluid noted intraoperatively.It was reported that the metal ion levels were elevated and ct showed osteolysis; however, neither the levels, lab reports, nor medical imaging were provided.Without the supporting lab/pathology results or relevant imaging, the root cause of the reported elevated metal ions, corrosion, osteolysis, and discolored fluid 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 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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETLR CUP HAP 58MM 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: 8905066
• MDR Text Key: 154683784
• Report Number: 3005975929-2019-00288
• 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: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Catalogue Number: 74120158
• Device Lot Number: 89939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Patient Sequence Number: 1
• Treatment: 71356113 ANTHOLOGY HO POROUS SZ 13 07GM13222; 74122550 HEMI HEAD 50MM 07MW15135; 74222100 MODULAR SLEEVE -4MM 12/14 08JW19029; FEMORAL HEAD, PART AND LOT # UNKNOWN; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention