MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 32 +0; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71369715

Device Problem Off-Label Use (1494)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2022

Event Type  Injury  

Event Description

It was reported that, during a thr, a mi trial fem head 32 +0 came off and got stuck inside the patient.Even though attempts were made towards retrieving the device, they were unsuccessful.Finally, the trial was left inside the patient due to the patient's anatomy.Surgery was resumed, with a backup device, but it remains unspecified if there was a delay.No complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6.The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, although no supporting clinical documentation was provided, it was reported during a total hip arthroplasty on a very obese patient, while doing a trial reduction the trial femoral head came off.It is noted, ¿it levered on something because the leg was so heavy and the trial was sucked up into the body fat.¿ per the report, unsuccessful attempts were made both manually and with x-ray to locate the trial femoral head.The trial head remains in situ and the ¿patient has declined further exploration.¿ the trial head is made of colored polyphenylsulfone (ppsu) and is not approved for long-term internal tissue exposure and long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include procedural/user error or surgical complication.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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.H11: corrected information in h6 (health effect - impact code).

• Brand Name: MI TRIAL FEM HEAD 32 +0
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 15715036
• MDR Text Key: 302854647
• Report Number: 1020279-2022-04646
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010555618
• UDI-Public: 03596010555618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71369715
• Device Catalogue Number: 71369715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention