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

Model Number	75002701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a tha had been performed, the sl-plus standard stem 4 non-cemented fractured.The patient has history of multiple previous operations.It is unknown whether the stem has been revised to this date or not.The current status in the patient's health is also unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: a revision surgery was reported due to a fractured sl-plus standard stem 4 non-cemented.The device in scope, which intent use is in treatment, was not returned for investigation.The fractured stem was presented on x-ray (b)(6) 2020.The x-ray was submitted for review.The submitted document, a report to the swiss medic agency does not reveal a reason for the breakage only that it happened with a minor movement.The impact to the patient beyond the pain, the revision surgery and the recovery cannot be determined.It is noted the patient has had several prior surgeries on her left hip.With the limited information provided the root cause of the femoral stem fracture cannot be confirmed and it cannot be concluded that the fracture and subsequent revision were associated with a malperformance of the implant.The patients history of prior surgeries on her left hip cannot be ruled out as a contributing factor.A product history review did not reveal any conclusions about the reported failure.For this specific batch no other complaint was recorded, since manufacturing of the batch back in 2001.The risk of an implant breakage is a rarely but known risk which is mentioned in our corresponding risk file as well as in our current instruction for use for hip implants lit.In conclusion, based on the very limited information the clinical root cause of this breakage cannot be concluded.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.S+n will monitor this device for similar issues.

• Brand Name: SL-PLUS STANDARD STEM 4 NON-CEMENTED
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11284667
• Report Number: 9613369-2021-00063
• Device Sequence Number: 4371941
• Product Code: KWY
• UDI-Device Identifier: 07611996078664
• UDI-Public: 07611996078664
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K072852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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 Model Number: 75002701
• Device Catalogue Number: 75002701
• Device Lot Number: 0110.60.4241
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 05/10/2021
• 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
• Patient Age: 73 YR