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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9613369-2021-00317
• Device Sequence Number: 17313076
• Product Code: LWJ
• UDI-Device Identifier: 07611996118568
• UDI-Public: 07611996118568
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: 75100465
• Device Catalogue Number: 75100465
• Device Lot Number: B2016721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention