MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74122158

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

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 07/16/2009

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to infection.An irrigation and debridement was performed.No parts were explanted.

Manufacturer Narrative

H3, h6: it was reported that right hip revision surgery was performed due to infection.An irrigation and debridement was performed.No parts were explanted.The implanted devices were used in treatment.Additional information has been requested for this complaint but has not become available.A review of the complaint history for the bhr cup, anthology stem, hemi head, modular sleeve 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 head, cup and stem.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.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.All the released devices involved met manufacturing specifications at the time of production.It was also confirmed that the cup, sleeve and head were sterilised.Sterilisation documentation could not be located for the stem.A non-conformance has been raised to investigate this.The production documentation for the stem confirms it was sent on a sterilization shipment.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.The available medical documents were reviewed.Based on the information provided, the patient¿s reported clinical symptoms were related to his multiple infections, which led to the irrigation and debridement procedure.The source of the infections cannot be determined, although he was reported to have decreased albumin, consistent with chronic inflammation.It cannot be concluded that the reported irrigation and debridement was associated with a mal-performance of the implant.The patient impact beyond the irrigation and debridement procedure and expected post-operative healing/pain cannot be determined.Without more information we cannot further investigate the details supplied in this complaint, our investigation remains inconclusive and a definitive root cause cannot be determined.Based on the limited information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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.

• Brand Name: ACETABULAR CUP HAP SIZE 52/58
• 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: 10331883
• MDR Text Key: 200592367
• Report Number: 3005975929-2020-00272
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552310
• UDI-Public: 03596010552310
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74122158
• Device Catalogue Number: 74122158
• Device Lot Number: 08HW18629
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71357104 / 08EM09138A - ANTHOLOGY HO POR PL HA SZ.; 74122552/08GW18131 - HEMI HEAD 52MM.; 74222200/08CW16021-MDLR SLEEVE {} PLUS 0MM 12/14.; 71357104 / 08EM09138A - ANTHOLOGY HO POR PL HA SZ; 74122552/08GW18131 - HEMI HEAD 52MM; 74222200/08CW16021-MDLR SLEEVE {} PLUS 0MM 12/14
• Patient Outcome(s): Required Intervention