MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 5 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100468
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr surgery performed on (b)(6) 2021, a revision surgery was performed on (b)(6) 2021 due to pain and dislocation of the oxinium femoral head 12/14 taper 32mm -3 and the polarstem standard non-cemented with ti/ha 5, the surgeon said the devices were not defective.Current health status of the patient is unknown.
Additional Manufacturer Narrative
It was reported that, after a total hip replacement surgery performed on (b)(6) 2021, a revision surgery was performed on (b)(6) 2021 due to pain and dislocation of the oxinium femoral head 12/14 taper 32mm -3 (b)(4) and the polarstem standard non-cemented with ti/ha 5 (b)(4) the surgeon said the devices were not defective.The products, which intent use is in treatment, were not returned for investigation.Per subsequent e-mail, no relevant clinical information will be provided for inclusion in this medical investigation.Therefore, a thorough medical investigation could not be rendered nor could a clinical root cause be determined.The production record of the polarstem hip stem did not reveal any discrepancy.For the batch in scope no other complaint was reported.There's no indication that the device failed to meet specification at time of manufacturing.In our current instruction for use for hip implants [lit.12.23, ed.03/21] joint dislocation is named as a potential adverse device effect.The risk is covered within our product specific risk file.No statement about contributing factors can be made after the performed possible investigations.No corrective or preventive actions are planned.The root cause remains undetermined.There's no relation between device and reported failure detectable and the failure can not be determined.Should additional information like detailed clinical information get available in future, the case will be re-assigned.Smith + nephew will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 5 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 12446542
• Report Number: 9613369-2021-00356
• Device Sequence Number: 3516175
• Product Code: LZO
• UDI-Device Identifier: 07611996118599
• UDI-Public: 07611996118599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2024
• Device Model Number: 75100468
• Device Catalogue Number: 75100468
• Device Lot Number: B1708992
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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: Hospitalization; Other