MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN R3 SCREW; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNKN01100906

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2013

Event Type  Injury  

Event Description

It was reported, after a left tha procedure was performed on the (b)(6) 2011, the patient experienced a dislocation, and a ct scan workup showed a large pseudotumor.A revision surgery was performed on the (b)(6) 2013 to treat this adverse event.During the revision surgery, a large metallosis area was found and the top surface of the acetabular cup was worn away.One of the screws that held the cup in place broke while trying to remove it and a piece remains inside the patient.The patient supported the procedure and was taken to the recovery room.

Manufacturer Narrative

Internal reference number: (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

The reported event was analyzed.It is unknown which of the two screws reported broke; therefore, both ref 20mm ball head screw and ref 30mm ball head screw were investigated.The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the broken tip of the screw that remained in situ is an implantable device and noted to be within the bone, so micromotion and/or migration is unlikely.The surgeon noted, ¿it was not a hindrance to any further of the surgery.¿ the patient impact beyond the reported events cannot be determined with the available information.No further clinical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for total hip systems revealed in warnings and precautions that the implant can break or become damaged as a result of activity or trauma.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with material specification, the quality and manufacture of wrought titanium 6al-4v eli alloy shall be controlled.The material may be used for surgical implants and be considered to be surgical grade titanium at this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique and/or excessive forces.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN R3 SCREW
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17651008
• MDR Text Key: 322290343
• Report Number: 1020279-2023-01682
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKN01100906
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2023
• 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): Other
• Patient Age: 60 YR
• Patient Sex: Male