MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID US COCR LNR 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Test Result (2695)

Event Date 02/11/2019

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to intense pain and elevated metal levels.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Our clinical/medical team confirmed that based on the limited information provided, the root cause of the patient¿s reported pain, elevated cocr levels and altr which necessitated a revision cannot be concluded but the contraindicated use of competitor devices with the smith & nephew r3 devices cannot be ruled out.It cannot be concluded that the reported reactions/events were associated with a mal-performance of the s&n implant.The patient impact beyond the revision and expected post-operative healing/pain cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.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 have no 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 for this failure mode was conducted.Factors and/or potential probable causes that could have contributed to the reported event include but are not limited to contamination, patient condition/reaction, and a post-operative healing issue.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.Be re-opened.We consider this investigation closed.

• Brand Name: R3 38MM ID US COCR LNR 50MM
• 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: 8503277
• MDR Text Key: 141577262
• Report Number: 3005975929-2019-00166
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD PART UNKNOWN AND LOT # UNKNOWN; SHELL 71331950, LOT # UNKNOWN; STEM 76539430, LOT # UNKNOWN; FEMORAL HEAD PART UNKNOWN AND LOT # UNKNOWN; SHELL 71331950, LOT # UNKNOWN; STEM 76539430, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention