MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT TRIAL BODY SZ 12-15; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 71354631

Device Problems Break (1069); Fitting Problem (2183)

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

Event Date 05/26/2021

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, the proximal redapt trial body sz 12-15 (b)(4) could not be fully seated.It was tapped down, and upon attempt to extract with the hook extractor it came apart at the pivoting junction leaving the distal part behind and the piece was removed.Also, the femoral head/neck impactor (b)(4) corner broke off when removing femoral head; the piece was retrieve.Instruments internal to patient.The procedure was successfully completed without delay and it was unknown how the procedure was finished.No patient injury or other complications were reported.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file 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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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: REDAPT TRIAL BODY SZ 12-15
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11977183
• MDR Text Key: 255453809
• Report Number: 1020279-2021-05109
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00885556578605
• UDI-Public: 00885556578605
• Combination Product (y/n): N
• PMA/PMN Number: K151902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71354631
• Device Catalogue Number: 71354631
• Device Lot Number: 15MPG0019
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention