MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MI TRIAL FEMORAL HEAD 36MM +4; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	75100857
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during total hip replacement, one (1) trial femoral head 36 m/+4 broke.It is unknown if pieces fell into the patient.The procedure was resumed, without any delay, using the same device.Patient was not harmed as consequence of this problem.
Event or Problem Description
It was reported that, during total hip replacement, one (1) mi trial fem head 36 +4 broke.It is unknown if pieces fell into the patient.The procedure was resumed, without any delay, using the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H11- corrected data: b5 - describe event or problem d1/d2a/d2b - brand name, product code, common device name.D3- manufacturer name, city and state.D4- catalog number, udi.Section g- contact office - manufacturing site.G3 / g4- 510(k)number.This report was inadvertently submitted under manufacturer number 9613369, the correct manufacturer number is 1020279.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed one of the inner tabs is broken off.The piece was not returned.This device shows signs of significant wear and use.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.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 specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should 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: MI TRIAL FEMORAL HEAD 36MM +4
• Common Device Name: 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: 16806909
• Report Number: 9613369-2023-00141
• Device Sequence Number: 19380409
• Product Code: HRY
• UDI-Device Identifier: 03596010559937
• UDI-Public: 03596010559937
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100857
• Device Catalogue Number: 71369722
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/21/2023; 05/18/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/17/2023; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown