MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 75007308

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

It was reported that some rust has starting to form in the sl-plus/sbg/ipa mia offset adapter 40mm.No procedure related.

Manufacturer Narrative

It was reported that some rust has starting to form on the sl-plus/sbg/ipa mia offset adapter 40mm (b)(4).This is not a procedure-related complaint and therefore, no injuries or surgical delays were reported.The device of (b)(4), intended for use in treatment, was returned for investigation.Upon visual inspection, the reported corrosion failure mode could be confirmed.The device shows signs of superficial corrosion.The corrosion is mostly located in circular accumulation or on edges and junctions of the device.Furthermore, some signs of wear such as dents and scratches could be observed.A review of the production documentation, including the material certificates, did not reveal any deviation from the standard operating procedure.Furthermore, no additional complaint with batch g51306 was reported.It is unclear if insufficient cleaning from organic residues contributed to the corrosion of the instrument.The accumulation of the corrosion might be related to the used sterilization/ cleaning procedure.Smith & nephew provides detailed information on cleaning and sterilization of instruments in leaflet lit.No.03389, ed 11/19.Based on the executed investigation steps, the root cause of this issue stays undetermined.The need for corrective action is not indicated.Smith & nephew will continue to monitor this device for similar issues.

• Brand Name: SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 40MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10857340
• MDR Text Key: 219177416
• Report Number: 9613369-2020-00238
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07611996074895
• UDI-Public: 07611996074895
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75007308
• Device Catalogue Number: 75007308
• Device Lot Number: 651308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1