MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 45OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 71324045

Device Problems Connection Problem (2900); Device Dislodged or Dislocated (2923); Misassembly by Users (3133)

Patient Problem Joint Dislocation (2374)

Event Date 07/11/2021

Event Type  Injury  

Event Description

It was reported that, after thr surgery had been performed with a tandem intl bipolar 45od 28id on (b)(6) 2021, in which surgeon had a hard time to click the ring in the head, the patient experienced a hip dislocation.This adverse event was solved by a revision surgery on (b)(6) 2021.The current health status of patient is unknown.

Manufacturer Narrative

Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The analysis shows that the explant shows light scratch and wear mark.A functional evaluation was conducted and concluded that the device was still functional while being damaged from implantation and extraction.A dimensional evaluation was conducted and concluded that the device was within specification excluding the damaged areas.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.The clinical/medical evaluation concluded that the provided photo of the ring was reviewed; however, alone it does not aid in the medical investigation.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.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are prior actions related to this product and failure mode.The prior action concluded that the previous event occurred due to a procedural variant.The contribution of the device to the reported event could not be corroborated.Possible causes could include but not limited to an abnormal motion/manipulation performed, patient anatomy or surgical technique.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.

Event Description

It was reported that, after a hip hemiarthroplasty had been performed on (b)(6) 2021, the hip luxated the next day: the tandem component dissociated from the head.The surgeon had a hard time to click the ring of the tandem intl bipolar 45od 28id into the head upon implantation.This adverse event was solved by a revision surgery on (b)(6) 2021 to explant both tandem and head implants.

Event Description

It was reported that, after a hip hemiarthroplasty had been performed on (b)(6) 2021, the hip luxated the next day: the tandem component dissociated from the head.The surgeon had a hard time to click the ring of the tandem intl bipolar 45od 28id into the head upon implantation the day before.This adverse event was solved by a revision surgery on (b)(6) 2021 to explant both tandem and head implants.Upon this revision surgery, it was found that the locking ring had been malpositioned in the shell.The current health status of patient is unknown.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.A dimensional evaluation was performed, and critical features for the returned product were evaluated for conformance to drawing print requirements.Of the measured features, the lock ring component was out of tolerance for multiple features.All of these features were oversized.The noted deviations above have the potential to cause the complaint as stated, but the surface of the part is visually damaged due to the assembly process in surgery and subsequent use by the patient.Plastic is easily distorted during attempted implantation, especially when attempting to mate with a rigid surface like the tandem shells.These surface finish defects (dings, scratches, scuffs, rubs) are enough to alter the measured reading during evaluation.All other measured features were within drawing print tolerances, including internal spherical radius.The clinical/medical evaluation concluded that with the information provided, we cannot rule out a procedural/user error as a contributory factor to the reported mal-positioned locking ring, luxation, and subsequent revision.It cannot be concluded the reported events were associated with a malperformance of failure of the implant.The future impact to the patient beyond the revision cannot be determined; however, it is noted ¿things were going well.¿ 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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are prior actions for the same device, however with the information provided at this time, they cannot be linked to the reported event.The contribution of the device to the reported event could not be corroborated.Possible causes could include but not limited to wrong positioning of the ring.This issue was identified and it was addressed though our quality hold process.Evaluation performed of the parts returned under the quality hold, did not indicated that a manufacturing issue could have caused the reported event.In addition, as part of our internal quality process, further investigation performed, in order to identify preventive actions.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: TANDEM INTL BIPOLAR 45OD 28ID
• 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: 12243755
• MDR Text Key: 264036165
• Report Number: 1020279-2021-06093
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010494368
• UDI-Public: 03596010494368
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71324045
• Device Catalogue Number: 71324045
• Device Lot Number: R2129410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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: 71302800, COCR 12/14 FEM HEAD/LOT:21DT48673
• Patient Outcome(s): Hospitalization; Required Intervention