MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 2 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 75100465

Device Problem Break (1069)

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

Event Date 07/02/2021

Event Type  Injury  

Event Description

It was reported that, during a tha surgery, the plastic cover on a polarstem stem std ti/ha 2 non-cem neck broke without any force or pressure applied to it.It is unknown how the procedure was finished.Patient was not harmed as consequence of this problem since all the fragments were retrieved.

Manufacturer Narrative

It was reported that, during a total hip arthroplasty surgery, the cone protector on a polarstem stem std ti/ha 2 non-cem broke without any force or pressure applied to it.It is unknow how the procedure was finished.Patient was not harmed as consequence of this problem since all the fragments were retrieved.The product including cone protector was not returned for investigation, but a picture of the fractured cone protector was provided.The failure mode can be confirmed.The packaging component, the cone protector is completely destroyed and shattered into many small pieces.The production records did not reveal any deviation which could explain the occurred fracture of the cone protector.For the batch in scope no other complaint was recorded.There is no indication that the device failed to match specification at the time of manufacturing.The risk is covered within our corresponding risk file.In our current ifu for hip implants lit.12.23 ed.05/16 it is stated that a device shouldn't be used if a packaging component including the cone protector show any damage.A that point and after the performed investigation the failure mode can not clearly be confirmed.The material of the protective cover could have been affected by climatic conditions, e.G.Storage, distribution, etc.Nevertheless, the root cause can not be independently established.No corrective or preventive actions are planned.Should additional information or the product get available in future this case will be re-assessed.Smith & nephew will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 2 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12159859
• MDR Text Key: 261273686
• Report Number: 9613369-2021-00317
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996118568
• UDI-Public: 07611996118568
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75100465
• Device Catalogue Number: 75100465
• Device Lot Number: B2016721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention