MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN R3 IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 75018402

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/30/2021

Event Type  Injury  

Event Description

It was reported that, after a thr had been performed, the stem subsided.This adverse event was addressed through revision surgery to exchange liner, head and stem.The patient outcome is unknown.

Manufacturer Narrative

D4, h6: it was reported that, after a total hip replacement had been performed, the stem subsided.This adverse event was addressed through revision surgery to exchange liner, head and stem.The patient outcome is unknown.The claimed device is a polarstem collar standard ti/ha size 2 stem, which intent use is in treatment was not returned for investigation.The production record could not be reviewed due to missing batch number.Furthermore a batch related complaint history review could not be performed.Therefore it can not be stated that the device met specifications at the time of manufacturing.Due to increased complaints reporting a subsiding/migration of polarstem stems in the last time a product related complaint history review was performed.For this specific type of stem additional complaints were recorded with similar failure mode.The failure mode and the severity of the reported issue are covered through the corresponding risk management files.The ifu (lit.No.12.23, ed.05/16) lists "dislocation, subluxation, insufficient range of movement, undesirable shortening or lengthening of the limb, as well as repositioning of the implant" among the possible side effects resulting from total hip arthroplasty.Responses to the requests for clinical documentation/information have not been received as of the date of this review, therefore the root cause of the reported stem subsidence could not be fully assessed nor concluded and remains undetermined.Due to insufficient information a relationship between device and event cannot be confirmed.Should these information like adequate clinical data and/or batch number get available in future, this complaint will be re-assessed and further investigations can be performed.Until further information is provided, no further activities are planned.S+n will monitor this device for similar issues.

• Brand Name: UNKN R3 IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11716575
• MDR Text Key: 247013806
• Report Number: 9613369-2021-00167
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75018402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention