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 a 75100213 polarstem case (b)(4) is damaged.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 to smith and nephew memphis.Upon visual inspection, the reported failure mode could be confirmed.The tray shows signs of wear and tear.Due to the wear, the batch number could not be detected on the tray.Based on the available information, the reported failure is attributed to a wear problem and the root cause is an ¿end of life problem¿ 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: 10857342
• MDR Text Key: 217129611
• Report Number: 9613369-2020-00239
• 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: 12/15/2020

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: 12/11/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1