MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY); PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number UNKN1102901

Device Problem Osseointegration Problem (3003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Hip Fracture (2349); Inadequate Osseointegration (2646)

Event Date 02/19/2024

Event Type  Injury  

Event Description

It was reported that, after a thr primary surgery, a revision was performed on (b)(6) 2024, due to pain, bone fracture around the stem, and loosening of the stem.The primary surgery was carried out on an unknown date; and a tandem bipolar cup, an oxinium femoral head, and a sl-plus mia ha stem were implanted.During the revision surgery an accord cable was used to attend the bone fracture, the head was exchanged for an oxinium femoral head, and the bipolar cup and stem were not changed.No more information is available.

Manufacturer Narrative

Internal reference number: case (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Manufacturer Narrative

It was reported that, after a total hip replacement primary surgery, a revision was performed on (b)(6) 2024, due to pain, bone fracture around the stem, and loosening of the stem.The primary surgery was carried out on an unknown date; and a tandem bipolar cup, an oxinium femoral head, and a sl-plus mia ha stem were implanted.During the revision surgery an accord cable was used to attend the bone fracture, the head was exchanged for an oxinium femoral head, and the bipolar cup and stem were not changed.The device intended for use in treatment was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the production history review was not possible.Due to insufficient information, it is not possible to perform a review of past corrective actions.As the batch number and part number are unknown, it is not possible to perform a complaint history review.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Insufficient information was made available to determine the revision of the instructions for use applicable to the device at the time of manufacturing.However, a review of the current revision was conducted, and it revealed that the instructions for use (lit.No.12.23, ed.03/21) states "hip fracture", "pain" and "loosening of implant not related to bone-ingrowth" as ¿potential adverse device effects¿ and "potential medical device problems" in combination with the implantation of a hip prosthesis.Based on the limited information provided, the revision due to pain, the bone fracture around the stem, (possibility secondary to the patient¿s pre-existing history of fragilitas ossium, due to her paralysis) and loosening of the stem.Therefore, it cannot be concluded that this was a mal performance of the s+n implant or an implant failure.The performed investigation does not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to indicate factors which could have contributed to the reported event.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: UNKN. SL-PLUS FAMILY STEM (UNKN. SUB-FAMILY)
• 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: 18896281
• MDR Text Key: 337577751
• Report Number: 9613369-2024-00022
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKN1102901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• 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
• Patient Sex: Female