MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 42OD 26ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 71302608

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a primary thr surgery performed on (b)(6) 2023, the patient suffered a dislocation on (b)(6) 2023 due to changing position on the bed.A manual reduction was performed but the dislocation could not be recovered.During manual reduction, the doctor heard abnormal noise.Then, a revision surgery was performed on (b)(6) 2023 and it was found that the cocr 12/14 fem head 26 + 8 had disassociated from tndm bp shl/xlpe lnr 42od 26id, even though poly ring was seated on the tandem bipolar.Patient current health status is unknown.

Manufacturer Narrative

Additional information: d9, d10.H3, h6: the associated devices were returned and evaluated.A visual inspection of the returned tandem liner revealed scratches on the device.The ring returned revealed a gouge in it.The femoral head was returned as well and the visual revealed scratches.The devices show signs of wear.A dimensional evaluation performed on the device revealed that critical features for the returned product were evaluated for conformance to drawing print requirements.Multiple measured features were out of tolerance.However, the part was noticeably warped from use in surgery, the part did not sit flush on the coordinate measuring machine fixture during measurement routine.Therefore, any measured features cannot be reliable since the part was involved in surgery and patient use.For the reasons above, the cause of the complaint cannot be confirmed as the result of a non-conforming part.There does not appear to be a systemic failure across multiple parts of this manufacturing batch at this time.The clinical/medical investigation concluded that, it was reported, after a primary total hip replacement on (b)(6) 2023, the patient suffered a dislocation on (b)(6) 2023 due to changing position on the bed.Therefore, there were no clinical factors found which would contributed to the reported events.The patient impact beyond the reported manual reduction and subsequent revision cannot be determined.No further clinical assessment 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 femoral head, 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.For the liner, 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.For the femoral head, a review of the instructions for use documents for total hip systems revealed that dislocation has been identified in warnings and precautions, that may result from improper selection of the neck length and cup, stem positioning, muscle looseness and/or malpositioning of components.For the liner, a review of the instructions for use documents for endoprostheses systems revealed that care must be taken to assess the viability of the acetabular hyaline cartilage and the presence of any irregularity, anomaly, or surface configuration which may predispose to subluxation and/or dislocation of the prosthesis as a warning.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 specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, patient anatomy, postoperative care and/or abnormal loading of limb.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.D1, d2a, d2b.

• Brand Name: TNDM BP SHL/XLPE LNR 42OD 26ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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: 16372461
• MDR Text Key: 309494861
• Report Number: 1020279-2023-00322
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2023

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
• Device Operator: Health Professional
• Device Model Number: 71302608
• Device Catalogue Number: 71325042
• Device Lot Number: 21AM17243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/06/2023; 08/24/2023
• Supplement Dates FDA Received: 03/06/2023; 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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: 71302608/COCR 12/14 FEM HEAD 26 + 8
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female