MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM -3; PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT

Catalog Number 71342803

Device Problems Corroded (1131); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Local Reaction (2035); Toxicity (2333); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 10/08/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients left hip on (b)(6) 2018 due to painful left hip and poor function; failed left total hip replacement; adverse local tissue reaction and subsequent infection.Among the intra-operative findings and diagnoses were aseptic loosening at the modular junction, corrosion of the modular neck and metallosis.The head, sleeve and stem were removed.The patient outcome is unknown.

Manufacturer Narrative

Adding g4 since follow up #2 was not sent with it.

Manufacturer Narrative

It was reported that a left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.Without definitive part/lot numbers a manufacturing review, device history review & complaint history review cannot be performed for the devices involved.If this information becomes available at a later time, the task will be reopened and completed.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.No medical documents were received.The reported event cannot be assessed and a thorough medical assessment cannot be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.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

*manufacturing site has been changed*.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the clinical information provided, of the pain, the corrosion and the metallosis, may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.It cannot be concluded that the reported clinical findings are associated with the implant failure.The root cause of the ¿aseptic loosening¿ cannot be concluded.It is a common complication and the combination of components cannot be ruled out as a contributing factor.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, design of device, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 28MM -3
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAIND, MET/CERAM/POLY, CEMNTD OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 10599312
• MDR Text Key: 209004047
• Report Number: 3005975929-2020-00368
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/03/2021

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: No Information
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: 71342803
• Device Lot Number: 11HM01257
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/12/2020; 10/12/2020; 11/26/2020; 08/02/2021
• Supplement Dates FDA Received: 10/14/2020; 12/03/2020; 12/08/2020; 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR HEAD SLEEVE; MODULAR HEAD SLEEVE
• Patient Outcome(s): Hospitalization; Required Intervention