MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71333334

Device Problems Crack (1135); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr performed on (b)(6) 2009, a revision surgery was required on (b)(6) 2021 to replace an old reflection liner (ref required 32 20 deg 50 52 e) that was cracked.The current health status of patient is unknown.

Event Description

It was reported that, after a thr performed on (b)(6) 2009, a revision surgery was requiered on (b)(6) 2021 to replace an old reflection liner (ref xlpe 32 20 deg 50 52 e) that was cracked.The current health status of patient is unknown.Visual inspection of the returned device revealed a fractured insert.

Manufacturer Narrative

B5: describe event or problem.Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed a fractured insert.A lab analysis performed on the device revealed that no material or manufacturing deviations were observed in the liner.The liner shows significant deformation from wear.Yellowish discoloration of the polyethylene of implants can occur when exposed to fluids in or around a joint.Black coloration is observed on an edge that could possibly be caused by wear debris from the femoral head contacting the metal shell over time.There is gouging and scratches along the top of the liner that could have possibly been caused by extraction.It is not possible to determine the cause of the wear in the liner nor the cause of the fragment breaking away from the liner from this investigation.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the reported event cannot be determined.No further clinical assessment 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 implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone, 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.The quality and manufacture of polyethylene shall be controlled according with the material specification.A review made by the quality engineering team revealed that this complaint is not able to have dimensional evaluation performed due to the damage incurred on the part based on photo provided.The failure mode shown in the photos does not raise concerns, as the polyethylene implant is expected to weaken over time, based on feedback from hip product development and research and development groups.This deterioration is influenced by multiple factors (including patient factors, environmental factors, surgical factors, mating surface factors, etc.) and can manifest in different ways.There is no reason to imply dimensional or functional defect(s) at this time considering product use-life was 11+ years.Additionally, this is the only complaint for the indicated batch.For the reasons stated above, no further escalation or actions will be pursued.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, excessive forces and/or traumatic injury.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.H6: medical device problem code.

• Brand Name: REF XLPE 32 20 DEG 50-52 E
• 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: 15901325
• MDR Text Key: 304681632
• Report Number: 1020279-2022-04875
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010455673
• UDI-Public: 03596010455673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2015
• Device Model Number: 71333334
• Device Catalogue Number: 71333334
• Device Lot Number: 05JM08153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OXINIUM FEM HD 12/14 32MM +8, LOT#:05KM05527; REF LNR 32X 50-52 20DG SZ E, LOT#:05KM05527
• Patient Outcome(s): Required Intervention
• Patient Sex: Female