MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR STD. TI/HA 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75018403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Unequal Limb Length (4534)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Us legal.It was reported that, after a tha surgery had been performed in (b)(6) 2018, the patient started to develop the following series of symptoms: chronic/debilitating pain, si joint inflammation, difficulty walking, leg length discrepancy, instability, bursitis, issues with her vision that required surgery, hair loss, skin rash, difficulty laying on her side, a callus on her hip and the patient can hear it move.This situation is ongoing.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, after a total hip replacement surgery had been performed in sep 2018, the patient started to develop the following series of symptoms: chronic/debilitating pain, joint inflammation, difficulty walking, leg length discrepancy, instability, bursitis, issues with her vision that required surgery, hair loss, skin rash, difficulty laying on her side, a callus on her hip and the patient can hear it move.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.A complaint history review was performed.The occurrence of the reported failure mode is within its expected risk level as per risk management.Due to insufficient information, it is not possible to perform a review of past corrective actions and a relationship between the reported event and the device cannot be confirmed.Based on the available information, it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.The reported failure mode pain is stated as a potential adverse device effect in the hip instruction for use of smith and nephew (lit.No.12.23 ed.03/21).Furthermore, the failure mode and the severity are covered in the corresponding risk management document.A medical investigation could not be performed due to insufficient information available.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.Should more information become available, the investigation will be reopened.No further actions are deemed necessary at this time.Smith+nephew will continue to monitor this device for similar issues.

• Brand Name: POLARSTEM COLLAR STD. TI/HA 3
• 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: 14503258
• Report Number: 9613369-2022-00265
• Device Sequence Number: 5732707
• Product Code: LZO
• UDI-Device Identifier: 07611996103403
• UDI-Public: 07611996103403
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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: 75018403
• Device Catalogue Number: 75018403
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: R3 0 DEG XLPE ACET LNR 32MM X 48MM; R3 3 HOLE ACET SHELL MM48; UNKN FEM HEAD MEMPHIS OX
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female