MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV COCR 14/16 FEM HEAD 32MM +8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 129966

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Injury (2348); Joint Dislocation (2374)

Event Date 10/25/2020

Event Type  Injury  

Event Description

It was reported that, after a tha had been performed, the femoral head disassociated with the stem.A revision surgery was necessary; the sales representative attended the revision, where the surgeon noticed severe damage to the stems trunnion and had to remove the stem in order to proceed with a full revision.When the femoral head was retrieved, it was confirmed that the wrong taper was originally used and was ultimately the cause of the disassociation/damage.The patient current status of health is unknown.The stem that had been initially implanted was a size 0 standard collared polartstem, and instead of the correct 12/14 tapered femoral head, a 32mm +8 large tapered 14-16 head was accidentally picked by the nursing staff and implanted into the patient.The sales representative had not been present during this surgery, as covid-19 restrictions prohibited vendors from entering the hospital at the time of surgery.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on the surgeon¿s statement, ¿when the femoral head was retrieved, it was confirmed that the wrong taper was originally used and was ultimately the cause of the dissociation/damage;¿ we cannot rule out a user vs procedural error as the likely cause of the reported event and not the performance of the smith and nephew device.Due to the limited documentation provided, the impact to the patient beyond the incorrect product implantation, disassociation and revision cannot be determined.Should any additional medical information be provided this complaint will be re-assessed.Therefore, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but are not limited to procedural variance or user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: UNIV COCR 14/16 FEM HEAD 32MM +8
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10857510
• MDR Text Key: 216816023
• Report Number: 1020279-2020-06552
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010087515
• UDI-Public: 03596010087515
• Combination Product (y/n): N
• PMA/PMN Number: K870128
• 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: 08/21/2021

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 Model Number: 129966
• Device Catalogue Number: 129966
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 08/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention