MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS INTEGR MIA STEM WITH TI/HA 8; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75000181
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery performed on (b)(6) 2021, the patient experienced a dislocation.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The sl-plus integr mia stem with ti/ha 8 was explanted and replaced with a competitor device.
Additional Manufacturer Narrative
H3, h6: it was reported that, after total hip replacement surgery performed on (b)(6) 2021, the patient experienced a dislocation.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The sl-plus integr mia stem with ti/ha 8 was explanted and replaced with a competitor device.The tndm bp shl/xlpe lnr 47od 26id was also explanted.The following investigation relates to the explanted and claimed sl-plus integr mia stem with ti/ha 8, which intent use is in treatment.The device was not returned.The production record reveal no deviation which could explain the occurred dislocation.Furthermore no additional complaint was recorded, neither for the batch in scope nor for the specific article.It will be not assumed that the device failed due to manufacturing.The risk of a dislocation is covered through our current risk file.Furthermore the risk is known and stated in our current instruction for use for hip implants.To date and after the possible investigations a relationship between the event and the device can not be confirmed.The root cause remains undetermined.Potential contributing factors can not be identified.Smith and nephew has not received the device/ adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case will be re-opened for further evaluation.Smith and nephew will monitor this device for similar issues.

• Brand Name: SL-PLUS INTEGR MIA STEM WITH TI/HA 8
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11803322
• Report Number: 9613369-2021-00200
• Device Sequence Number: 19810555
• Product Code: LZO
• UDI-Device Identifier: 07611996092837
• UDI-Public: 07611996092837
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 75000181
• Device Catalogue Number: 75000181
• Device Lot Number: C1922690
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention