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

Model Number	75100474
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a thr on (b)(6) 2021, a revision surgery was performed on (b)(6) 2022 due to accumulating water.The polarstem stem lat.Ti/ha 1 non-cem was explanted.The surgeon says it was not caused by infection.No causative microorganism (bacteria) is detected.Also, the surgeon did not think s+n devices were defective.It is unknown the current health status of the patient.
Additional Manufacturer Narrative
H3, h6: it was reported that, after a total hip replacement on (b)(6) 2021, a revision surgery was performed on (b)(6) 2022 due to accumulating water.The surgeon reported that it was not caused by infection.The device, used in treatment was not returned for evaluation, therefore further analysis was not possible.Therefore, the relationship between the reported event and the device cannot be confirmed.However, based on the communicated information, the product history could be reviewed.The production documentation was reviewed.There are no indications that the part failed to match specification at the time of manufacturing.There were no further complaints reported for the batch in scope.The failure mode and the severity are covered through the corresponding risk management files.The ifu lit.No.12.23, ed.03/21 lists the reported failure mode as potential adverse device effect.Review of past corrective actions was performed.No further escalation is required.Since no medical information was shared, a medical investigation could not be conducted.The root cause stays undetermined after investigation.Based on the limited information it is not possible to speculate about factors which could have contributed to the reported issue.To date, further actions are not deemed necessary.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this device for further similar issues.

• Brand Name: POLARSTEM STEM LAT.TI/HA 1 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
• 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: 13619488
• Report Number: 9613369-2022-00038
• Device Sequence Number: 11864592
• Product Code: LZO
• UDI-Device Identifier: 07611996118650
• UDI-Public: 07611996118650
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100474
• Device Catalogue Number: 75100474
• Device Lot Number: C2134023
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male