MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 48MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120148

Device Problems Material Fragmentation (1261); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348); Test Result (2695)

Event Date 08/17/2018

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to continuous pain, metallosis, elevated chromium and cobalt levels, hypertonic synovium and extensive yellowish fibrous caseating material.

Manufacturer Narrative

It was reported that the left 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 bhr cup, bhr head, hemi head, and modular 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 stem and sleeve.Similar complaints have been identified for the hemi head.However, as the device is no longer sold, no action is to be taken.Similar complaints have been identified for the bhr cup.However, as bhr systems of this size are no longer sold, no action is to be taken.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 and no further actions are required at this time.The available medical documents were reviewed.The 40° of anteversion of acetabular cup cannot be ruled out as a contributory factor the reported pain and elevated metal ions if they are due to wear, but cannot be confirmed.Although the reported pain, elevated metal ions, osteolysis and trunnions may be consistent with findings associated with metallosis; the root cause of the reported clinical 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.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 48MM 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: 9699769
• MDR Text Key: 178766290
• Report Number: 3005975929-2020-00055
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502551
• UDI-Public: 03596010502551
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2013
• Device Model Number: 74120148
• Device Catalogue Number: 74120148
• Device Lot Number: 094690
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74222200 MOD SLEEVE PLUS 0MM 12/14 10BW25772; HEMI HEAD 74122542/ 09CW12838; SYN POR HO STEM 71306111/ 07KM01853; HEMI HEAD 74122542/ 09CW12838; SYN POR HO STEM 71306111/ 07KM01853
• Patient Outcome(s): Hospitalization; Required Intervention