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 Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Ossification (1428); Synovitis (2094); Test Result (2695)

Event Date 04/15/2019

Event Type  Injury  

Event Description

It was reported a right hip revision surgery due to heterotopic ossification, black staining and synovial tissue with chronic inflammation.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the hemi head and modular sleeve were removed.The synergy stem and acetabular cup 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.Without definitive part/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part numbers known for the involved devices in search of complaints involving loosening throughout the lifetime of the product.Similar complaints have been identified and this failure will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review and ifu review could not be performed.A risk management review was performed.No additional risks were identified as result of the reported event.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 on the reported avascular necrosis, loosening of the acetabulum, and reported trunnionosis.The reported pain and elevated metal ions along with heterotopic ossification noted on radiological exam as well as intraoperative findings of black staining to the trunnion and heterotopic ossification in the region of the vastus ridge may be consistent with findings associated with metal debris and trunnionosis.Without the analysis of the explanted components, the root cause of the reported loosening, avascular necrosis, and trunnionosis 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: 9676575
• MDR Text Key: 177976248
• Report Number: 3005975929-2020-00043
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 74122546/ UNKNOWN.; MODULAR SLEEVE 74222100/ UNKNOWN.; SYN POR STEM 71309012/ UNKNOWN.; HEMI HEAD 74122546/ UNKNOWN; MODULAR SLEEVE 74222100/ UNKNOWN; SYN POR STEM 71309012/ UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR