MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 4 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	75002701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery had been performed on (b)(6) 2021, the patient experienced pain and fracture.This adverse event was treated with a revision surgery on (b)(6) 2021.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: it was reported that, after thr surgery had been performed on (b)(6) 2021, the patient experienced pain and fracture.This adverse event was treated with a revision surgery on (b)(6) 2021.The sl-plus standard stem 4 non-cemented (75002701) intended for use in treatment was not returned for investigation.An evaluation of the complained device could therefore not be conducted and the reported failure mode could not independently be confirmed.Based on the limited information provided, a thorough medical assessment could not be performed.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record revealed no deviations from the standard manufacturing process that could have contributed to the reported issue.The ifu (lit.No.12.23 ed 05/16) lists the reported issue as a known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the performed investigation, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.A root cause cannot be determined.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: SL-PLUS STANDARD STEM 4 NON-CEMENTED
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12267408
• Report Number: 9613369-2021-00336
• Device Sequence Number: 14717979
• Product Code: KWY
• UDI-Device Identifier: 07611996078664
• UDI-Public: 07611996078664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75002701
• Device Catalogue Number: 75002701
• Device Lot Number: I2126660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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; Required Intervention