MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 4 NON-CEMENTED; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75002701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to broken stem's neck.This was noticed upon x-rays after the patient was received in the hospital with pain.
Additional Manufacturer Narrative
Results of investigation: a revision surgery was performed due to fracture in the neck area of a sl standard stem.It was reported that the patient was brought to hospital due to pain in his hip.An x-ray confirmed that the neck of the stem was broken.Only x-rays but no further medical documents were received for investigation.Additionally it was reported that the patient underwent two ball head and cup revisions due to recurrent dislocations of the hip.It is unknown when the initial surgery took place.A medical assessment concludes that the root cause of the neck breakage cannot be determined.There was no thorough medical assessment possible due to missing medical documentation.Based on the received x-rays it can be confirmed that the neck of the sl stem broke.Additionally it is visible that there was some stem subsidence, however it cannot be determined if this happened before the neck breakage.The broken sl stem and the ball head, used in treatment, were received for investigation.A material assessment showed that 2/3 of the fracture surface show fatigue striations, indicating that the crack propagated by fatigue under low to medial stress.In the area of the assumed crack initiation on the outer surface of the stem, a discolored spot is visible, which is supposed to have been there before breakage of the stem.Such spot might be caused by electrocautery which could have led to fracture initiation.A visual analysis can confirm the breakage.Several scratches can be observed in the neck of the stem.Also the ball head shows some signs of use.The combination of the ball head and the sl stem is approved by smith and nephew.The risk of a neck breakage is covered through our risk management files in severity and failure mode.The production documentation of the ball head was reviewed, there were no deviations found.A complaint history review did not reveal any further neck fracture complaints for the combination of products in scope.The documentation history review could not be performed for the stem, as no batch number of the implant was available without a destructive analysis.Based in the performed investigation, the failure mode of neck breakage can be confirmed.The root cause can not be determined after investigation.It cannot be excluded that the deformations on the neck, which might have happened during the ball head revisions, contributed to the fatigue fracture.To date, further actions are not deemed necessary.Smith and nephew will monitor this device for further similar issues.Both devices will be retained.

• Brand Name: SL-PLUS STANDARD STEM 4 NON-CEMENTED
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 9365367
• Report Number: 9613369-2019-00094
• Device Sequence Number: 2256193
• Product Code: LZO
• UDI-Device Identifier: 07611996078664
• UDI-Public: 07611996078664
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K072852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 75002701
• Device Catalogue Number: 75002701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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: 75004149, PLUS METAL METAL BALL, LOT: A06571
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR