MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OR3O DUAL MOBILITY TRIAL LINER 38/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 71353302

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported that, during a thr surgery, the screw and ring of the or3o dual mobility trial liner 38/50 became disassociated from plastic during trialing.Instruments inside patient.All pieces recovered.Procedure finished with same device.Delay of five minutes reported.

Manufacturer Narrative

H3,h6: the device, used in treatment, was returned for evaluation.A visual inspection confirmed the or3o dual mobility trial liner 38/50 shows nicks.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: OR3O DUAL MOBILITY TRIAL LINER 38/50
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10816925
• MDR Text Key: 215515846
• Report Number: 1020279-2020-06343
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00885556710456
• UDI-Public: 885556710456
• Combination Product (y/n): N
• PMA/PMN Number: K191002
• 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: 02/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71353302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention