MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TNDM BP SHL/XLPE LNR 41OD 26ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Catalog Number 71325041

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/07/2023

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr revision surgery, the patient suffered from dislocation and disassociation of the tndm bp shl/xlpe lnr 41od 26id again.It was stated that dislocation was caused because the patient could not comply with the surgeon¿s instructions due to dementia and took away abduction brace.Also, it was stated that stem neck impingement may have occurred during manual reduction which caused the disassociation.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: the associated devices were returned and evaluated.A visual inspection of the returned devices does not reveal any defects.A dimensional evaluation was conducted and found features only on the plastic parts were out of tolerance.This is most likely due to the autoclaving process.The autoclaving process puts high temperature steam which can distort the dimensions of the product on plastic parts.Out of tolerance features do not appear to be from manufacturing.Therefore no other orders were affected.The clinical/medical investigation concluded that, as of the date of this medical investigation, supporting clinical documentation has not been provided; however, it is noted the ¿dislocation was caused because the patient could not comply with the surgeon¿s instructions due to dementia and took away abduction brace.¿ as well, it is noted the ¿stem neck impingement may have occurred during manual reduction which caused the disassociation.¿ therefore, there were no clinical factors found which would have contributed to the reported dislocation and disassociation.The patient impact beyond the reported events cannot be determined with the limited information provided.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed device.For the tandem bipolar shell, a review of the instructions for use documents for endoprosthese systems revealed in adverse effects that dislocations, subluxations, decreased range of motion, or lengthening or shortening of the femur, caused by improper neck selection, positioning, looseness of components or extraneous bone may occur.Also for the femoral head, a review of the instructions for use documents for total hip systems revealed for postoperative warnings and precautions the need of warning patients against unassisted activity, particularly use of toilet facilities and other activities that require excessive motion of the hip, as they may result in subluxation or dislocation.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.For the tandem bipolar shell, a review concluded that a similar event was found related to dislocation, and escalated actions were opened.The listed batch was not part of the impacted product.For the femoral head, 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 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 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.

• Brand Name: TNDM BP SHL/XLPE LNR 41OD 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: 16478350
• MDR Text Key: 310608464
• Report Number: 1020279-2023-00438
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71325041
• Device Lot Number: 19MM16844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2019
• 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: COCR 12/14 FEM HEAD 26 + 4 / 71302604 / 21MM05781.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female