MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71368569

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/27/2019

Event Type  Injury  

Event Description

It was reported that during surgery device broke and parts of the broken device remained inside of the patient.It is unknown if a revision surgery has been schedule.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.One of the pins, that holds one of the swivel joints together on the drive shaft, was missing.The device was manufactured in 2013 and exhibits signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.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 product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The medical investigation concluded that the requested clinical information nor radiographs were not provided.Based solely, on the visual inspection the root cause of the implant breakage was likely due to age related wear.The reported retained foreign body is neither bio-inert nor approved for implantation.Per email, according to the surgeon, ¿the foreign substance is still inside the patient' joint and the place that the foreign substance was retained is not the articular surface.At this time, the foreign substance is unlikely to move into the inside the articular surface.¿ a revision surgery has not been scheduled at this time.The future impact to the patient cannot be determined.No further clinical/medical assessment is warranted at this time.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.

• Brand Name: R3 OFFSET IMPACTOR
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8712951
• MDR Text Key: 148446338
• Report Number: 1020279-2019-02339
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010600240
• UDI-Public: 03596010600240
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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 Catalogue Number: 71368569
• Device Lot Number: 13KM09569
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/19/2019
• Supplement Dates Manufacturer Received: 05/27/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention