MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 1 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	75002695
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a hemiarthroplasty had been performed, the patient experienced pain due to stem loosening.A revision surgery was performed to explant stem, oxinium head and bipolar head.The patient outcome is unknown.
Additional Manufacturer Narrative
It was reported that the patient who has implanted a smith and nephew stem, a bipolar head and an oxinium head is suffering from pain and loosening of stem.The initial surgery was (b)(6) 2011 and the revision surgery was planned on (b)(6) 2020.The surgeon states that the s+n devices were not defective.The devices, used in treatment, were not returned for investigation nor has any batch number been reported.Also from a medical investigation perspective, no documentation was received to fully evaluate the complaint and the patient current status is unknown.An appropriate investigation could therefore not be conducted.The instruction for use at the time of implantation (lit.-nr.12.23 ed.07/10) states loosening as a known possible adverse effect in combination with the implantation of a hip prosthesis.Furthermore, the failure mode and the severity is covered through our risk management.To conclude, based on the available information, the root cause of the reported issue cannot be confirmed and the reported loosening of stem cannot be confirmed.Based on available information, the need for corrective action is not indicated.The complaint will be reopened should additional information be received.Smith and nephew will continue to monitor this device for similar issues.

• Brand Name: SL-PLUS STANDARD STEM 1 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: 10679854
• Report Number: 9613369-2020-00213
• Device Sequence Number: 14243565
• Product Code: KWY
• UDI-Device Identifier: 07611996078633
• UDI-Public: 07611996078633
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 75002695
• Device Catalogue Number: 75002695
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/04/2020
• 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: 71342804; 75004339; 71342804; 75004339
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention