MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SYNERGY HIP STEM; PRSTHSS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL, METAL/POLYACETAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/22/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patient right hip due to experiencing pain and limping on the right side.It was discovered he experienced elevated cobalt and chromium levels in (b)(6) 2019.The patient outcome is unknown.

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.Due to lack of device details provided, a documentation review could not be performed for the devices reportedly involved in this incident.If further information is received, the documentation review will be reopened and completed.The available medical documents were reviewed.Although elevated metal ions were reported, neither the lab values or laboratory reports were provided.Without status post implantation and pre-revision x-rays and/or the analysis of the explanted components; the root cause of the reported pain, limping and femoral component loosening cannot be confirmed and it cannot be concluded that the reported events were associated with a mal-performance of the implant; however, the reported pain and limping may be consistent with symptoms associated with the loosened femoral component.The patient¿s history of morbid obesity with a bmi>50 and avascular necrosis cannot be ruled out as contributing factors to his pain and clinical status.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.

Manufacturer Narrative

H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the patient underwent a right hip revision surgery.After further clarification and information received, it was determined that this event does not involve a femoral stem.Since the patient received a right hip resurfacing (bhr) system, the only two involved implants are a resurfacing head and acetabular cup (reported under 3005975929-2020-00297 and 3005975929-2020-00296 respectively).This complaint against a synergy hip stem will be voided.

• Brand Name: UNKNOWN SYNERGY HIP STEM
• Type of Device: PRSTHSS,HIP,HEMI-,TRUNNION-BEARING,FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks rd.; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10411813
• MDR Text Key: 203085755
• Report Number: 1020279-2020-03961
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention