MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM EXTRACTOR BLOCK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 75004678

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the polarstem extractor block broke while trying to slap out an implanted polar stem.The procedure was completed using a s+n backup device.No injury to the patient was reported.A surgical delay of 30 min or less was reported.The newly implanted stem had to be extracted because the surgeon was not able to reduce the hip after implanting.As a result, the stem was downsized and sat lower in the canal, creating room for the hip to be reduced.

Manufacturer Narrative

Investigation results: it was reported that the extraction block broke while trying to slap out an implanted polar stem.The procedure was completed using a s+n backup device.The newly implanted stem had to be extracted because the surgeon was not able to reduce the hip after implanting.As a result, the stem was downsized and sat lower in the canal, creating room for the hip to be reduced.The device, used in treatment, was not returned for investigation.The production documentation was reviewed, there are no indications that the device failed to match specification at the time of manufacturing.One further complaints was reported for the batch in scope, however, the two complaints are not regarding the same failure mode.The failure mode and the severity are covered through the corresponding risk management files.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.The failure mode was not independently confirmed, as the device was not returned for investigation.The root cause is attributed to a design issue.To date, the need for further actions is not given.Should the device be returned, this case will be reassessed.Smith and nephew will monitor this device for further similar issues.

• Brand Name: POLARSTEM EXTRACTOR BLOCK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11169250
• MDR Text Key: 226764648
• Report Number: 9613369-2021-00034
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07611996109399
• UDI-Public: 07611996109399
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 75004678
• Device Catalogue Number: 75004678
• Device Lot Number: B60296
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention