MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN R3 METAL LINER IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71332754

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

Patient Problem Failure of Implant (1924)

Event Date 10/16/2009

Event Type  Injury  

Manufacturer Narrative

Complaint reference: case-(b)(4).

Event Description

Patient underwent medically-indicated revision of the r3-tha right hip implant.The patient revision surgery was performed on (b)(6) 2009, due to unknown reasons.Only the r3 metal liner, head and sleeve were explanted.

Manufacturer Narrative

H3, h6: 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.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / instructions for use review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The dislocation and subsequent revision was related to the patients reported ¿fall down some stairs¿ and is not associated with a mal-performance of the implant.The patient impact beyond the reduction 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

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 dislocation and subsequent revision was related to the patients reported ¿fall down some stairs¿ and is not associated with a mal-performance of the implant.The patient impact beyond the reduction cannot be determined.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.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.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: UNKN R3 METAL LINER IMPL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10938350
• MDR Text Key: 219307400
• Report Number: 3005975929-2020-00478
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 71332754
• Device Lot Number: 09DM03479
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention