MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXI FM HEAD 14/16 TPR 36 +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71342368

Device Problems Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)

Patient Problems Discomfort (2330); Implant Pain (4561); Insufficient Information (4580)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr construct had been implanted on the patient¿s hip on (b)(6) 2021, the patient sustained unspecified symptoms.The surgeon discovered an incompatibility issue between the femoral head and neck implant, for which he advised that a revision surgery was necessary.This intervention was performed on (b)(6) 2022.

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, smith and nephew has not received the explanted device and/or adequate materials to fully evaluate the complaint.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue, procedural variance or user 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.

Manufacturer Narrative

H10.Additional information in h6 (health effect - clinical code).H11.Corrected information in b5 and h6 (medical device problem code).

Event Description

It was reported that, after a thr construct had been implanted on the patient¿s hip on (b)(6) 2021, the patient suffered from pain and discomfort.The surgeon discovered a size incompatibility issue between the femoral head and neck implant, for which he advised that a revision surgery was necessary.This intervention was performed on (b)(6) 2022.The patient required additional physical therapy and a prolonged recovery time.

Manufacturer Narrative

Additional information in: b5, b7, d1, d2, d4, d10, g4, and h4.Corrected information in b3 and h6.

Event Description

It was reported that, after a thr construct had been implanted on the patient¿s hip on (b)(6) 2021, the patient suffered from pain and discomfort.The surgeon discovered a size incompatibility issue between the femoral head and neck implant on (b)(6) 2022, for which he advised that a revision surgery was necessary.This intervention was performed on (b)(6) 2022 and the femoral head was explanted and replaced with one of the correct size.The patient required additional physical therapy and a prolonged recovery time.

Event Description

It was reported that, after a thr construct had been implanted on the patient¿s hip on (b)(6) 2021, the patient suffered from pain, discomfort and persisting clicking present within right hip.The surgeon discovered a size incompatibility issue between the femoral head and neck implant on (b)(6) 2022, for which he advised that a revision surgery was necessary.This intervention was performed on (b)(6) 2022 and the femoral head was explanted and replaced with one of the correct size.The patient required additional physical therapy and a prolonged recovery time.On (b)(6) 2022 patient reports resolution of pain with except occasional ache, and also denies clicking within right hip.

Manufacturer Narrative

The reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the oxinium femoral head 14/16 taper 36mm +8 neck.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the initial implanted 36 mm oxinium head¿s taper was 14/16 and the polarstem cone¿s taper is 12/14.The polarstem¿s instructions for use states that ball heads should only be combined with smith & nephew hip stems of identical taper dimensions and from smith & nephew orthopaedics ag (or formerly plus orthopedics, intraplant or plus endoprothetik).Additionally, the surgeon must always ensure that the individual components are compatible.Therefore, human error is the likely contributing factor to the reported size incompatibility issue between the femoral head and neck implant.It is unknown whether the incompatible taper sizes led to the reported pain and clicking the patient experienced.The impact to the patient beyond that which has already been reported cannot be determined.However, two weeks post revision, the patient reported resolution to pain except an occasional ache and continued to advance in his activities with home exercise program without the use of assistive devices for ambulation.No further clinical 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 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 correct selection of the implant is extremely important.The appropriate type and size should be selected for patients with consideration of anatomical and biomechanical factors such as patient age, activity levels, weight, bone and muscle conditions, any prior surgery and anticipated future surgeries, etc.This has been identified as an intraoperative warning and precaution.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.A factor that could contribute to the reported event include user/procedural variance.Based on this investigation, the need for corrective action is not indicated.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 +8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 14655130
• MDR Text Key: 294856157
• Report Number: 1020279-2022-02873
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010502285
• UDI-Public: 03596010502285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71342368
• Device Lot Number: 17MM09474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71332756 / LOT 20LM07757; 71335556 / LOT 21FW08199; 75018406 / LOT B2010828
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male