MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS MIA STEM 3 NON-CEM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 75001941

Device Problem Failure to Osseointegrate (1863)

Patient Problems Muscle Weakness (1967); Discomfort (2330); Arthralgia (2355); Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 11/07/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that after a right thr surgery had been performed on an unknown date, the patient experienced shaft loosening.This adverse event was treated by a revision surgery on (b)(6) 2023.Current health status of patient is unknown.

Manufacturer Narrative

H10; additional information: updated section a3, a4, b5, b7, d6a and h6 (clinical code).

Event Description

It was reported that after a right thr surgery had been performed on (b)(6) 2012, the patient experienced shaft loosening, pain and feeling of weakening muscle.This adverse event was treated by a revision surgery on (b)(6) 2023.Patient left the hospital if stable conditions without further need of strong pain killers or antibiotics.

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).D6a: the hospital has informed that the index surgery occurred on (b)(6) 2023 in a different hospital (kantonsspital uri), while the production records confirm this prosthesis was manufactured on (b)(6) 2023.Further documentation regarding this procedure, along with other medical documentation pertaining to the patient's clinical course has not been provided to the designated unit to further investigate this incident.Results of investigation: it was reported that after a right toal hip replacement (thr) surgery had been performed on (b)(6) 2012, the patient experienced shaft loosening, pain and feeling of weakening muscle.This adverse event was treated by a revision surgery on (b)(6) 2023.Patient left the hospital if stable conditions without further need of strong pain killers or antibiotics.The complaint sample was returned for evaluation.Upon visual inspection, slight signs of bone material deposits and dicolorations are visible at both sides of the distal part of the hip stem.Additionally, heavy scratches and dents are visible around the proximal neck of the stem.It is assumed that the scratches and dents originate from the stem removal procedure.Upon material assessment, partial bone-ingrowth could be identified on the distal part of the stem but most of the surface area shows no signs of bone-ingrowth.Shiny spots could be identified and are indicating a repeated rubbing of the implant against the bone tissue.A review of the product documentation did not detect any deviation that could have contributed to the reported failure mode.The review of historical complaints for the alleged device revealed no additional similar complaints reported for the same batch, and no additional similar complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.A review of the device labeling revealed that the current ifu (lit.No.12.23, ed.03/21) states muscle weakness, pain and osseointegration problem of the component as a ¿potential adverse device effect¿ in combination with the implantation of a hip prosthesis.Further, a clinical/medical evaluation has been performed.As of the date of the performed medical investigation none of the requested supporting clinical documentation has been provided, no clinical factors which would have contributed to the reported shaft loosening, pain and feeling of weakening muscle were found.Based on the available information and the performed investigation, the reported failure mode could be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.The root cause of the reported issue remains unknown.The need for further actions is not indicated.Smith and nephew will continue to monitor this device for similar issues.This investigation is considered closed.The returned complaint sample will be retained.Corrected data: b1 (type of event), b3 (occurrence date), b5 (narrative), h6 (health effect - clinical code).

Event Description

It was reported that after a right thr surgery had been performed on (b)(6) 2012, the patient experienced stem loosening, pain and feeling of weakening muscle.This adverse event was treated by a revision surgery on (b)(6) 2023.The patient left the hospital in stable conditions without further need of strong pain killers or antibiotics.

• Brand Name: SL-PLUS MIA STEM 3 NON-CEM
• Type of Device: 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
• 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: 18237332
• MDR Text Key: 329370050
• Report Number: 9613369-2023-00220
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996078879
• UDI-Public: 7611996078879
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K082371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2019
• Device Catalogue Number: 75001941
• Device Lot Number: B1213536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 11/30/2023; 12/22/2023
• Supplement Dates FDA Received: 11/30/2023; 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Sex: Female
• Patient Weight: 70 KG