MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM VALGUS TI/HA 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75102073
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right thr surgery performed on (b)(6) 2021, a (b)(6) female presented with increasing right hip region pain on mobilization.No reports of trip, falls or incidents.Ct and x-ray showed a fracture of the proximal femur with significant stem subsidence.Patient medical history includes overweight (bmi not known).Original polarstem subsided, so the stem and the head were removed.Orif was completed and a redapt stem and a new head were implanted on (b)(6) 2021.The original shell and liner were retained.Patient current health status is unknown due to hospital confidentiality policy.No further information available.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Additional Manufacturer Narrative
H3,h6: it was reported that, after a right total hip arthroplasty a patient presented with increasing right hip region pain on mobilization.No reports of trip, falls or incidents.Ct and x-ray showed a fracture of the proximal femur with significant stem subsidence.The device used in treatment was not returned for investigation, therefore, no product evaluation could be conducted.However, the provided x-rays confirm the reported issue.A malfunction of the device cannot be confirmed.A thorough medical assessment was not possible due to missing further information.The production documentation was reviewed, there are no indications that the part failed to match specification at the time of manufacturing.No further complaint was reported for the batch in scope.According to the ifu lit.No.12.23 ed.03/21, implant component migration is listed among potential device problems.The associated patient risk is low and covered in the risk management.Review of past corrective actions was performed.No further escalation is required.The root cause of the reported issue remains undetermined after investigation.It is not possible to speculate about contributing factors due to the limited amount of information.Should additional information or the device become available, this investigation will be reopened.To date, the need for further action is not indicated.Smith and nephew will monitor this device for further similar issues.

• Brand Name: POLARSTEM VALGUS TI/HA 1
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12828799
• Report Number: 9613369-2021-00412
• Device Sequence Number: 12443898
• Product Code: LZO
• UDI-Device Identifier: 07611996142334
• UDI-Public: 07611996142334
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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 Model Number: 75102073
• Device Catalogue Number: 75102073
• Device Lot Number: B1925824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female