MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 44MM ID INTL COCR LINER 56MM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number 71335856

Device Problem Biocompatibility (2886)

Patient Problems Ossification (1428); Metal Related Pathology (4530)

Event Date 05/21/2015

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

(b)(6) it was reported that after a right r3 tha was performed on (b)(6) 2009, the plaintiff experienced high metal ion levels on blood and heterotopic ossification.A first revision surgery was performed on (b)(6) 2015 to treat this adverse event.During the surgery, brown fluid in small quantities was found, additionally, several pieces of heterotopic ossification were found near the gluteus medius muscle.The liner and the femoral head components were explanted and exchanged.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.As of today, all of the devices used in treatment have not been returned, hence cannot be evaluated.Additional information for this complaint has been requested but has not become available.A review of the complaint history for the r3 liner, modular head, sleeve, r3 shell and stem was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the r3 liner, modular head, r3 shell or the stem.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.On account of the fact devices reportedly involved in this incident were not returned for evaluation, the relevant production records were reviewed.All released devices involved met manufacturing specifications at the time of production.Review of manufacturing records did not reveal any waivers, concessions, manufacturing, or material abnormalities that could have contributed to this issue.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.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.The reported elevated cobalt and chromium levels and the noted intraoperative findings of whitish tissue that pulls towards brown, and erosion at the head and neck junction may be consistent with findings associated with metal debris.However, the root cause of the reported clinical reactions cannot be confirmed, and it cannot be concluded that the reported reactions were associated with a mal performance of the implant.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined.Without return of the applicable devices or further information we cannot advance the investigation or confirm the details supplied in this complaint.Furthermore, our investigation remains inconclusive and a definitive root cause cannot be determined.Due to the insufficient information provided, we are unable to determine specific factors known to contribute to the alleged fault.If the devices or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: R3 44MM ID INTL COCR LINER 56MM
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 12519389
• MDR Text Key: 272915891
• Report Number: 3005975929-2021-00421
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010596123
• UDI-Public: 3596010596123
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2018
• Device Catalogue Number: 71335856
• Device Lot Number: 08CW15969
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR