MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 42MM ID INTL COCR LINER 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71335854

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/24/2014

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain, squeaking metal-on-metal hip with pseudotumor and elevated metal levels.

Manufacturer Narrative

It was reported that 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.A review of the complaint history for all devices reported in this complaint was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.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.No medical documents were received for investigation.Therefore no medical assessment could be performed.Further, it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.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 re-opened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: R3 42MM ID INTL COCR LINER 54MM
• 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: 8287242
• MDR Text Key: 134411805
• Report Number: 3005975929-2019-00036
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

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: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 71335854
• Device Lot Number: 09CW22276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD 42MM 74222142 LOT 08LW20146; HEAD SCREW 20MM 71332520 LOT 10ET42477; HEAD SCREW 35MM 71332535 LOT 10FM02056; MODULAR SLEEVE 74222300 LOT 08KW19693; R3 SHELL 54MM 71335554 LOT 10LM08244; SYN FEM COMP 71306614 LOT 10DM10840; HEAD 42MM 74222142 LOT 08LW20146; HEAD SCREW 20MM 71332520 LOT 10ET42477; HEAD SCREW 35MM 71332535 LOT 10FM02056; MODULAR SLEEVE 74222300 LOT 08KW19693; R3 SHELL 54MM 71335554 LOT 10LM08244; SYN FEM COMP 71306614 LOT 10DM10840
• Patient Outcome(s): Hospitalization; Required Intervention