MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEM HEAD MEMPHIS OX; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71343208
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr surgery performed on (b)(6) 2012 where an oxinium femoral head size 32, an r3 cup size 56 and a nanos stem size 6 were implanted.On (b)(6) 2022, patient experienced a subluxation on the right hip.When over lifting in the ambulance, there was a hip repositioning.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional 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 the requested x-ray images were not provided for review.Per the e-mail communication, no treatment was needed and the patient is "very well" following rest and physical therapy.Based on the limited information provided a thorough medical assessment could not be performed.Should additional information be provided, the clinical/medical investigation task will be reopened.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, it may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.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 traumatic injury, limited range of motion, patient anatomy, postoperative care or abnormal loading of limb.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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
B4: description updated.D4: part number, lot number, udi and expiration date added.D10: concomitants added.H4: manufactured date added.
Event or Problem Description
It was reported that after a thr surgery performed on (b)(6) 2012 where an oxinium femoral head size 32, an r3 cup size 56 and a nanos stem size 6 were implanted.On (b)(6) 2022, patient experienced a subluxation on the right hip.No treatment was required, when over lifting in the ambulance, there was a hip repositioning.No further complications were reported.Current health status of the patient is very well.

• Brand Name: FEM HEAD MEMPHIS OX
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 15519431
• Report Number: 1020279-2022-04238
• Device Sequence Number: 2673965
• Product Code: JDG
• UDI-Device Identifier: 03596010474230
• UDI-Public: 03596010474230
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 71343208
• Device Catalogue Number: 71343208
• Device Lot Number: 10JM04344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 11/21/2022; 11/25/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/21/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NANOS FEMORAL NECK PROSTHESIS NONCEM 6; PN: 71336500 / LOT NUMBER: 11HM08880; PN: 71337656 / LOT NUMBER: 10JM04344; PN: 75008160 / LOT NUMBER: NL3071; PN: UNKN01100901 / LOT NUMBER: 11AM15054; UNKN R3 SHELL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female