MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	71343200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, the patient suffered from recurrent dislocations of the left hip on (b)(6) 2018 and (b)(6) 2019.Both events were treated via closed reduction for which the patient was sedated.The first dislocation occurred 3 weeks after the patient underwent a left hip revision surgery on (b)(6) 2018.The current state of health of the patient is unknown.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device was not returned for evaluation but the dislocation can be confirmed with the clinical/medical findings.The clinical/medical investigation concluded that, the first dislocation was noted to be a result of a twisting injury.At the time of the second dislocation, it was reported she was trying to put on pair of boots, which cannot be excluded as a likely contributing factor to the dislocation.The patient impact beyond the closed reductions cannot be determined with the information provided.It cannot be concluded if the ¿twisting injury¿ lead to the first and subsequent dislocation and a failure of the implant cannot be confirmed.No further investigation is warranted at this time.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 that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components, this has been identified as warnings and precautions.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 or abnormal loading of limb.The contribution of the device to the reported event could be corroborated as it required closed reductions.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.
Additional Manufacturer Narrative
Section h3, h6: given the nature of the alleged incident, the devices were not returned for evaluation however, the dislocation can be confirmed with the clinical/medical findings.The clinical/medical investigation concluded that, the first dislocation was noted to be a result of a twisting injury.At the time of the second dislocation, it was reported she was trying to put on pair of boots, which cannot be excluded as a likely contributing factor to the dislocation.The patient impact beyond the closed reductions cannot be determined with the information provided.It cannot be concluded if the ¿twisting injury¿ lead to the first and subsequent dislocation and a failure of the implant cannot be confirmed.No further investigation 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.For the oxinium femoral head a review of complaint history revealed similar events for the listed device over the previous 36 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.For the optifix xlpe anteverted a review of complaint history for the part number over the past 36 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that dislocation that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components, this has been identified as warnings and precautions.A review of the risk management files 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 these products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.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: OXINIUM FEM HD 12/14 32MM +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 15902008
• Report Number: 1020279-2022-04884
• Device Sequence Number: 14764935
• Product Code: LZO
• UDI-Device Identifier: 03596010474209
• UDI-Public: 03596010474209
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71343200
• Device Catalogue Number: 71343200
• Device Lot Number: 18HM15202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 12/26/2022; 05/31/2024
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 12/27/2022; 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• 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: OPTIFIX XLPE 46-48(PN: 71337646, LN:14CM04706)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female