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

Catalog Number 71325042

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after hemiarthroplasty had been performed on the (b)(6) 2011, the patient went to the hospital due to pain on or about (b)(6) 2022.It was found that the locking ring of the tndm bp shl/xlpe lnr 42od 26id came off during daily activities, resulting in dislocation of the outer cup and head.A revision surgery was performed on the (b)(6) 2022 to treat this adverse event where the tndm bp shl/xlpe lnr 42od 26id and the univ cocr 10/12 taper fem hd 26 mm +5 ext were explanted.The patient outcome is unknown.

Manufacturer Narrative

H3, h6: the associated devices were returned and evaluated.A visual inspection of the returned devices revealed signs of wear from use.According to the lab examination conducted by a subject matter expert, the examination showed scratching of the femoral head and shells, deformation of the femoral head taper and locking ring, and discoloration of the acetabular liner.The synergy femoral component was not returned for analysis.The scratching of the articulating surfaces of the femoral head and bipolar shell were likely due to third-body wear.The deformation of the femoral head was also likely due to explantation.The deformation of the locking ring likely occurred after it disassociated from the bipolar shell.The cause of the disassociation of the bipolar ring from the bipolar shell could not be determined from this analysis.The discoloration of the acetabular liner was likely to the absorption of biological fluids.A wear inspection was conducted by placing the femoral head into the bipolar shell construct and visually inspecting the conformity between the mating components.Based on this visual assessment, minimal gaps were observed indicating minimal wear of the acetabular liner.The clinical/medical evaluation concluded that smith and nephew has not received adequate materials to fully evaluate the complaint.Two photos of the returned device were reviewed, but do not provide insight into the reported problem.Per visual inspection ¿the returned device did not confirm the stated failure mode.The device has signs of prolonged use.¿ the findings of the prolonged use correlated with the implantation time of 11 years.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records of all parts did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the tandem bipolar shell, 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.A review of the instructions for use was performed, and the important medical information for endoprostheses systems reveals in the adverse effects section 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.For the universal femoral head and the synergy offset, 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 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management files revealed this failure mode was previously identified for all parts.The anticipated risk level is still adequate.For the universal femoral head and the synergy offset assessment of historical escalated cases concluded that there are prior actions related to this product and failure mode.For the tandem bipolar shell a review of previously escalated cases concluded that this failure was further investigated and addressed through training improvements, dimensional inspections added to production routers, release of new work instructions and update of existing ones and performance of process audits.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TNDM BP SHL/XLPE LNR 42OD 26ID
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 14431043
• MDR Text Key: 291961833
• Report Number: 1020279-2022-02394
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: 71325042
• Device Lot Number: 10LM08650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2010
• 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: SYN SEL II POR SO 10/12 SZ 12-11 CM17324; UNIV COCR 10/12 TAPER FEM HD 26 MM +5 EXT-10FM17578
• Patient Outcome(s): Required Intervention; Hospitalization