MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MODULAR SLEEVE {} PLUS 0MM 12/14; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	74222200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision hip surgery was performed on (b)(6) 2020 due to elevated hip effusion.Also, serum cobalt blood work report from showed elevated cobalt and chromium level.The modular metal head, the sleeve and the r3 metal liner were explanted.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting.The device reported here (modular sleeve {} plus 0mm 12/14 / 74222200) works in conjunction with the hemi head 42mm / 74122542 and is, therefore, considered a concomitant product.The mi head 42mm / 74122542 was already reported under report number: (b)(4) (our internal reference number: (b)(4)).We conclude that the event will be investigated under this last complaint mentioned.Therefore, this report will be closed as non-valid.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal reference: (b)(4).

• Brand Name: MODULAR SLEEVE {} PLUS 0MM 12/14
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10347411
• Report Number: 1020279-2020-03582
• Device Sequence Number: 2964338
• Product Code: KWL
• UDI-Device Identifier: 03596010552518
• UDI-Public: 3596010552518
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K062408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2014
• Device Catalogue Number: 74222200
• Device Lot Number: 09AW20999
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71291302,71335554,71332515,71332525, 71291665
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR