MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 32 + 0; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71303200

Device Problem Biocompatibility (2886)

Patient Problem Metal Related Pathology (4530)

Event Date 10/13/2020

Event Type  Injury  

Event Description

It was reported that, after a tha made on (b)(6) 2018 with implanted anthology hip impl and oxinium femoral head, the patient experienced an advanced metallosis.A revision surgery was performed on (b)(6) 2020 to explant the components.It is unknow what kind of implants were used to replace the explanted ones and if any other treatment or medication was administered to the patient in regards the effect presented.The patient outcome is unknown.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of wear/ damage from implantation and extraction.A dimensional evaluation of the returned device identified two features that were out of tolerance.The features that were out of tolerance could contribute to the failure mode via contact with the mating component.It is also noted that the presence of damage on the device could contribute to it being out of tolerance.The clinical/medical evaluation concluded that, per complaint details, ¿the patient experienced an advanced metallosis¿ and underwent revision approximately 2 years post implantation.It is unknow if any other treatment or medication was administered to the patient and the patient outcome is unknown.Responses to the requests for clinical documentation were not provided.The root cause and/or patient impact beyond that which was reported could not be further assessed.Should clinically relevant documentation/information and/or relevant product evaluation results become available, the clinical/medical task may be re-evaluated.No further medical assessment could be rendered at this time.A review of complaint history did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.Some potential probable causes for this event could include damage due to friction with mating components and patient allergy.Based on this investigation, the need for corrective action is not indicated.This failure was evaluated through our internal quality process, and concluded the head was implanted, and the taper surface was damaged due to this.Therefore the out of tolerance features a cannot be attributed to a manufacturing process.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

Event Description

It was reported that, after a tha made on (b)(6) 2018, the patient experienced an advanced metallosis.A revision surgery was performed on (b)(6) 2020 to explant an anthology stem and a cocr 12/14 fem head 32 + 0.The current patient's health status is unknown.

Manufacturer Narrative

Correction in section b5: femoral head explant of cocr.Not oxinium.

Manufacturer Narrative

Correction in b: femoral head explant of cocr.Not oxinium.

Event Description

It was reported that, after a tha made on (b)(6) 2018, the patient experienced an advanced metallosis.A revision surgery was performed on (b)(6) 2020 to explant an anthology stem and a cocr 12/14 fem head 32 + 0.The current patient's health status is unknown.

• Brand Name: COCR 12/14 FEM HEAD 32 + 0
• Type of Device: PROSTHESIS, 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11816976
• MDR Text Key: 250358153
• Report Number: 1020279-2021-04171
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71303200
• Device Lot Number: 18JT09579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• 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; Other