MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXI FM HEAD 14/16 TPR 36 +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER

Model Number	71342364
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tha surgery performed on (b)(6) 2022, a oxinium femoral head 14/16 taper 36mm +4 neck was implanted by mistake, as it was not noticed that it was the incorrect size.Patient underwent a revision surgery on (b)(6) 2022 to replace the oxinium femoral head 14/16 taper 36mm +4 neck with the appropriate 12/14 taper oxinium head.Patient did not report any symptoms prior to the revision.Patient is recovering from surgery.
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 implantation of the incorrect size and subsequent revision of the implant is a result of human error and is not associated with a mal performance of the implant or implant failure.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The printed labels in the manufacturing records were reviewed and they show the appropriate size in a clear way.A review of complaint history for the part number over the past 12 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 the surgeon should be thoroughly familiar with the implants, instruments, and surgical procedure prior to performing surgery.Have been identified as a possible adverse effect.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.Possible causes could include but not limited to surgical technique used or user/procedural variance.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.
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 implantation of the incorrect size and subsequent revision of the implant is a result of human error and is not associated with a mal performance of the implant or implant failure.The patient impact beyond the revision cannot be determined.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number and product family 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 the surgeon should be thoroughly familiar with the implants, instruments, and surgical procedure prior to performing surgery.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 intra operative error.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.

• Brand Name: OXI FM HEAD 14/16 TPR 36 +4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, 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: 14655113
• Report Number: 1020279-2022-02863
• Device Sequence Number: 14729818
• Product Code: JDI
• UDI-Device Identifier: 03596010502278
• UDI-Public: 03596010502278
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K914878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2022

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 Model Number: 71342364
• Device Catalogue Number: 71342364
• Device Lot Number: 19BM09028
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/15/2022; 12/06/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/18/2022; 12/07/2022
• Date Device Manufactured: 02/12/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 109 KG