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
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that some rust has starting to form in the sl-plus/sbg/ipa mia offset adapter 40mm.No procedure related.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2020-00239
• Device Sequence Number: 14112253
• Product Code: JDI
• UDI-Device Identifier: 07611996074895
• UDI-Public: 07611996074895
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1