MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS STANDARD STEM 0 NON-CEMENTED; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 75002718

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032)

Event Date 12/04/2023

Event Type  Injury  

Event Description

It was reported that, after undergoing primary thr in 1998, the patient required an unknown cup replacement in 2019.On 04-dec-2023, while bending down, the patient suddenly heard a cracking noise in the area of the right hip with immediate onset of pain and inability to move.X-rays revealed a sl-stem cone fracture.It was indicated that the patient will probably require a revision surgery, but this has not been confirmed yet.Patient's current health status is unknown.

Manufacturer Narrative

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

Manufacturer Narrative

H10- additional information d4- unique identifier (udi) # d9- date device returned to manufacturer.D10- concomitant medical products h11- corrected data.B5- describe event or problem.D1 - brand name.D4- lot number, catalog number.D6a / d6b ¿ implanted/explanted date.

Event Description

It was reported that, after undergoing thr revision on (b)(6) 2019 in which a sl-plus standard stem 0 non-cemented was placed in exchange of primary competitor devices, the patient suddenly heard a cracking noise while bending down in the area of the right hip with immediate onset of pain and inability to move on (b)(6) 2023.X-rays revealed a sl-plus standard stem 0 non-cemented cone fracture.This event was treated by performing a revision surgery on (b)(6) 2023, in which a new sl-plus size 2 stem was placed along with a 32mm oxinium femoral head.The patient presents no clinical signs of thrombosis.Circulation, motor function and sensitivity of the lower extremities are intact.The discharge x-rays of the hip joint document the correct position of the prosthesis.

Manufacturer Narrative

H11- corrected data.B5- describe event or problem.

Event Description

It was reported that the patient had a primary right tep on 1997 and after undergoing several right hip revision surgeries, on (b)(6) 1998 a sl-plus standard stem 0 non-cemented was implanted.Twenty-five (25) years later, the patient suddenly heard a cracking noise while bending down with immediate onset of pain in the right hip and inability to move on (b)(6) 2023.X-rays revealed a sl-plus standard stem 0 non-cemented cone fracture.This event was treated by performing a revision surgery on (b)(6) 2023, in which a new sl-plus size 2 stem was placed along with a 32mm oxinium femoral head.The patient presents no clinical signs of thrombosis.Circulation, motor function and sensitivity of the lower extremities are intact.The discharge x-rays of the hip joint document the correct position of the prosthesis.

Manufacturer Narrative

It was reported that, after undergoing primary total hip replacement in 1998, the patient required an unknown cup replacement in 2019.On (b)(6) 2023, while bending down, the patient suddenly heard a cracking noise in the area of the right hip with immediate onset of pain and inability to move.X-rays revealed a sl-plus standard stem 0 non-cemented cone fracture.Two parts were returned for investigation.An sl-plus standard stem size 0 and a third party cocr 32xl/+8 femoral head.A visual evaluation of the sl-plus stem was conducted, and it was concluded that it is fractured at it's neck.Apart from that, scratches around the fracture are visible, potentially originating from a clamp during attempted stem removal.At the distal end of the stem, signs of bony ingrowth are visible.An analysis of the fracture on the stem was done at the broken surface.It was found that the fracture originated at the lateral side of complained device.About two thirds of the fracture surface show fatigue striations, indicating that the crack propagated by fatigue.There is also dimples at the broken surface, characteristic of ductile overload.No pores, inclusions or elemental inhomogeneities which could have initiated or enhanced crack growth, could be observed on the fracture surface.In the area of assumed crack initiation, scratches and stainless steel residues have been found.Furthermore, discolorations on the polished surface could be attributed to an increased oxide layer thickness, presumably caused by the use of an electric scalpel.Some scratches and discolorations close to the region of assumed crack initiation span both fragments, indicating their presence prior to fracture (potential damage during primary or revision surgery).A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.The complaint history review for the complaint device revealed no additional complaints for the affected batch nor additional complaints for the same product number over the past 12 months with similar failure mode.A review of past corrective actions was performed.No previous escalation was found, and no further escalation is required.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The instructions for use states "implant component fracture" as a ¿potential medical device problem¿ in combination with the implantation of a hip prosthesis.The available medical documents were reviewed.The sl-plus standard stem was in situ for greater than 25 years.With the information provided, the patient history of multiple revision surgeries and a possible procedural variance cannot be ruled out as contributing factors to the reported event, as the product evaluation indicated damage to the stem prior to fracture, which may have led to crack initiation.The patient impact is the hip revision, and post operative convalescence period.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.The root cause of the reported event remains undetermined.It is suspected that the implant has been damaged during surgery while using an electric scalpel.And after years of regular mechanical stress, the constantly applied forces may have resulted in the confirmed fracture.The need for further actions is not indicated.Nevertheless, smith+nephew will continue to monitor this device for similar issues.The returned device will be retained.Internal complaint reference number: (b)(4).

• Brand Name: SL-PLUS STANDARD STEM 0 NON-CEMENTED
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18450136
• MDR Text Key: 332263642
• Report Number: 9613369-2024-00002
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996000542
• UDI-Public: 7611996000542
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75002718
• Device Lot Number: 94.336
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ZIMMER THR SYSTEM.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female