MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 52MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120152

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Ossification (1428); Failure of Implant (1924); Inflammation (1932)

Event Date 07/22/2019

Event Type  Injury  

Event Description

It was reported a left hip revision surgery due to synovium, significant acute inflammation and heterotopic ossification.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The acetabular cup and synergy stem 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 acetabular cup, hemi head and modular sleeve was performed using part numbers in search of similar recurring reports for the products during their lifetimes.A full complaint history review could not be performed due to no lack of full device details.Similar complaints, two of which are from the same patient/device, have been identified for the hemi head and sleeve and this failure will continue to be monitored.Similar complaints have been identified for the cup, however, these complaints are from the same patient/device.No batch numbers were provided; hence manufacturing record and ifu review could not be completed.If more information is received, this investigation will be reopened.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.It is unknown to what extent the patient¿s reported alcoholism could have affected his bone quality which could have also been a contributing factor to the reported avascular necrosis.The reported pain and elevated metal ions along with heterotopic ossification noted on radiological exam, and significant acute inflammation within the synovium, heterotopic bone as well as a black-gray adhered material consistent and fretting corrosion reported on pathological exam and intraoperative findings of a blackened taper and heterotopic bone may be consistent with findings associated with metal debris and synovitis.However, without the analysis of the explanted components the root cause of the metal debris and synovitis 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.In conclusion, based on the available information, 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.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 52MM 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: 9676788
• MDR Text Key: 177985286
• Report Number: 3005975929-2020-00044
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502575
• UDI-Public: 03596010502575
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 74120152
• Device Catalogue Number: 74120152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 74122546/ UNKNOWN; MODULAR SLEEVE 74222200/ UNKNOWN; SYN POR STEM 71309012/ UNKNOWN; HEMI HEAD 74122546/ UNKNOWN; MODULAR SLEEVE 74222200/ UNKNOWN; SYN POR STEM 71309012/ UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR