MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 42OD 22ID; PROST HIP, HEMI-, FEMORAL, METAL/POLY, CMNTD OR UNCMNTD

Catalog Number 71324042

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had a right-sided artificial femoral head replacement on june 19.No complications reported on first surgery.Post-operative review x-ray showed that the femoral stem implant was not in place and the tip penetrated the marrow cavity.The patient was able to extend and flex the right hip after the operation, and there was no significant pain or discomfort in the right femur during the operation, so the patient did not consider the possibility of a second operation.Although the stem is not in place.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

It was reported that the patient had a right-sided artificial femoral head replacement in (b)(6) 2020.No complications reported on first surgery.Post-operative review x-ray showed that the femoral stem implant was not in place and the tip penetrated the marrow cavity.The patient was able to extend and flex the right hip after the operation, and there was no significant pain or discomfort in the right femur during the operation, so the patient did not consider the possibility of a second operation.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.There is no information that would suggest the device failed to meet specifications.A review of the complaint history on the listed part revealed prior complaints for the listed failure mode with the same batch number.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A clinical analysis noted that based on the documentation provided, the root cause of the reported event could not be definitively concluded; however, multi-factorial conditions such as user-related surgical technique in the presence of a fractured femur with inadequate proximal femoral support in a deconditioned, osteoporotic, elderly patient could not be ruled out as contributing factors.The patient impact beyond the reported intra-op cleaving of the lateral femoral cortex, cerclage placement, and stem penetration/periprosthetic fracture could not be determined.Reportedly, there is no plan to revise as the patient was not experiencing pain and declined further surgical intervention.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TANDEM INTL BIPOLAR 42OD 22ID
• Type of Device: PROST HIP, HEMI-, FEMORAL, METAL/POLY, CMNTD OR UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11020241
• MDR Text Key: 221782409
• Report Number: 1020279-2020-07517
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 06951591805915
• UDI-Public: 6951591805915
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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: 71324042
• Device Lot Number: 18AB00286
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/20/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TANDEM INTL BIPOLAR 42OD 22ID (71324042); TANDEM INTL BIPOLAR 42OD 22ID (71324042)
• Patient Outcome(s): Other
• Patient Age: 87 YR