MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 6 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number 75002705

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Discomfort (2330); Ambulation Difficulties (2544); Implant Pain (4561)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a tha had been performed on (b)(6) 2001, the patient suffered a sprained trauma on (b)(6) 2022.A cracking noise was heard, pain was felt, and movement was restricted ever since.The patient presented to the hospital, and it was determined that the sl-plus standard stem 6 non-cemented fractured at the neck.A revision surgery was performed on (b)(6) 2022 to explant stem.The surgeon also made the decision to explant the rest of the system.Patient is doing well post-operatively.

Manufacturer Narrative

Results of investigation: it was reported that, after a total hip arthroplasty had been performed, the patient suffered a sprained trauma 21 years after surgery.At the hospital, it was determined that the sl-plus standard stem 6 non-cemented was fractured at the neck.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.The stem is fractured at the neck.A complaint history review was performed.No additional complaint for the batch in scope was reported so far and the occurence and severity are in line with the corresponding risk file.A review of the batch record was performed.No deviations from the standard manufacturing process were reported which could have contributed to the reported issue.The device was manufactured in year 2000.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A review of the device labeling revealed that the ifu states that activity such as sporadic stress or jumping in which the prosthesis is exposed to blows and/or excessive loads an adversely affect the results of the operation.According to the performed medical assessment, the patient had a left total hip arthroplasty in 2001 and a revision in 2015, where a bicon-plus pe insert and the ceramic ball head were replaced (refer to (b)(4)).Approximately seven years later, the patient had a second revision due to a fractured sl-plus stem.The provided x-rays taken four days prior to the second revision and the revision operative report confirmed the reported fracture located at the neck of the stem.The fracture of the stem occurred approximately 21 years after implantation.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the medical investigation.Based on the information provided, the patient¿s distortion trauma is likely the contributing factor to the stem fracture.The impact to the patient beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.Additionally, a detailed material analysis was performed.About two thirds of the fracture surface show fatigue striations, indicating that the crack propagated by fatigue.The residual fracture surface is covered by dimples, characteristic of ductile overload.No pores or inclusions, which could have initiated or enhanced crack growth, could be observed on the fracture surface.In the area of assumed crack initiation, scratches, stainless steel residues and discolorations from the potential use of an electric scalpel have been found which were likely present prior to fracture and may have led to crack initiation.To sum up, based on the performed investigations, the relationship between the reported event and the device was confirmed.However, the root cause could not be determined conclusively.Nevertheless, it cannot be excluded that a potential contact of an electric scalpel during the revision surgery initiated the fatigue fracture.Followed by the patient¿s distortion trauma, the stem is probably fractured then.No further actions are deemed necessary at this time.Smith+nephew will continue to monitor this device for similar issues.The returned device will be archived.For further information regarding the use of hf devices, please refer to the following bfarm recommendation "hüftprothesenschaftschädigung insbesondere im bereich des prothesen-halses durch einsatz eines hochfrequenz-chirurgie-instruments (hf-gerät)" (fall-nr.13822/19, https://www.Bfarm.De/shareddocs/risikoinformationen/medizinprodukte/de/hueftprothese_hf-chirurgie.Html).

• Brand Name: SL-PLUS STANDARD STEM 6 NON-CEMENTED
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13636277
• MDR Text Key: 286351200
• Report Number: 9613369-2022-00043
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 07611996078688
• UDI-Public: 07611996078688
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75002705
• Device Catalogue Number: 75002704
• Device Lot Number: 0012.13.4062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 75003554, BICON-PLUS PE INSERT STD 4/32, 1415037; 75003741, BICON-PLUS SHELL 4-52, 0011.13.4086
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 95 KG