MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71335558

Device Problem Connection Problem (2900)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  Injury  

Event Description

It was reported that, during surgery, after inserting the acetabulum cup 58mm, a 58mm poly liner compatible with the 58mm cup was tried to be used but could not be inserted.A second liner was tried (58mm 20 degree elevation type), but the same problem occurred.Finally, additional reaming was performed and a 60mm cup was used to complete the procedure.A delay greater than 30 minutes occurred without significant effect on the patient.

Event Description

It was reported that during surgery, after inserting the acetabulum cup 58mm, a 58mm poly liner compatible with the 58mm cup was tried to be used but could not be inserted, a second liner was tried (58mm 20 degree elevation type) but would still not work and a third liner was tried but the same problem occurred.Finally additional reaming was performed and a 60mm cup was used to complete the procedure.A delay greater de 30 minutes occurred without significant effect on the patient.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection could not confirm the stated failure.The device exhibits normal wear and use from attempted insertion of the implant.Dimensional evaluation was completed on the returned shell device for all ctq features critical to liner mating and function.No deviations were noted during dimensional evaluation.The failure mode cannot be confirmed via dimensional analysis of the device.A medical investigation was conducted and confirms per complaint the details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Without the requested clinical information a thorough medical investigation cannot be rendered.According to the report, the surgeon changed 1 shell to a larger size after three different liners would not seat.There were no deviations noted on the dimensional evaluation of the returned shell.Based on the information provided, the surgeon reamed an additional 2mm and a 60mm cup was used to complete the procedure.It was reported there was a delay of > 30-minutes without a significant impact on the patient.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint would be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: R3 3 HOLE ACET SHELL 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10649442
• MDR Text Key: 210421650
• Report Number: 1020279-2020-05251
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598271
• UDI-Public: 03596010598271
• Combination Product (y/n): N
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71335558
• Device Catalogue Number: 71335558
• Device Lot Number: 19KW07210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71331758 / 15CT52436; 71332758 / 18MM01522; 71335758 / 17KM00158
• Patient Outcome(s): Other; Required Intervention