MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number 71335556

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a thr procedure, the r3 3 hole acet shell 56mm disassociated with insertion handle upon impaction and therefore did not initially get impacted in the proper position.Therefore had to remove.Realized the central hole had cross threaded.Surgery was resumed after a non-significant delay, with a change in surgical technique.Patient was not harmed.

Manufacturer Narrative

The associated device was returned and evaluated.The visual inspection revealed the device shows signs of use during surgery.A dimensional evaluation performed on the device revealed the part to be out of specification for thread form.The product failed one step of final inspection and has visual damage in the threads.The part is non-conforming for thread form.The clinical/medical investigation concluded that, the surgical technique does address acetabular shell insertion and notes that close attention should be paid to initial positioning of the r3 shell.As of the date of this medical investigation, the supporting clinical documentation has not been provided; therefore, definitive clinical factors which could have contributed to the reported event could not be concluded.The patient impact beyond the reported shell exchange/modified surgical technique and surgical delay cannot be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.A review made by the quality engineering team revealed that the production documentation including the product assurance data sheet for the device was reviewed.All dimensions were confirmed as within specification and no damage was observed to the thread of any device within batch 22ew15746 on cell checks or final process checks.In order to perform the overall dimensional check the device is screwed onto a mount for measurement, this would not have been possible should damage have been present.The thread gauge check confirmed that the thread was not damaged during manufacture.A thread gauge was used to confirm that the thread mated correctly.Thread gauge was calibrated after 12 months, still in protective coating and had not been issued to production.The calibration was therefore extended for 12 months.No reported issue with any other device from the batch of 17, 13 of which have been sold assumed implanted.All dimensions noted as within specification during manufacture and no damage observed.Based on this evaluation it is believed the device was within manufacturing specifications at the time of production and that this is an isolated incident, which possibly occurred during surgery.No other similar complaints were noted to have occurred relating to warwick produced r3 shells within the last 12 months and no other complaints have been received relating to this batch.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include insertion technique used and/or user/procedural variance.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: R3 3 HOLE ACET SHELL 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 15392905
• MDR Text Key: 305411958
• Report Number: 1020279-2022-04035
• Device Sequence Number: 1
• Product Code: MBL
• UDI-Device Identifier: 03596010598264
• UDI-Public: 03596010598264
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71335556
• Device Catalogue Number: 71335556
• Device Lot Number: 22EW15746
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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