MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STANDARD 3 CEMENTED; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75002114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that while performing a revision surgery to exchange the poly to rule out infection, the surgeon went to dislocate the hip and the polarstem stem standard 3 cemented pulled right out.It is unknown if the extracted poly is a sn device.The outcome of the patient was not reported.
Additional Manufacturer Narrative
Case-(b)(4).B4: event description updated.
Event or Problem Description
It was reported that, after a tha had been performed on an unspecified date, the patient experienced a suspected infection.A revision surgery was performed to confirm/rule out the infection on (b)(6) 2021.Upon dislocation of the hip, the polarstem stem standard 3 cemented pulled right out.The stem and femoral head were explanted; it is unknown if the liner was explanted at the end, and so is its brand.The outcome of the patient was not reported.
Additional Manufacturer Narrative
It was reported that, after a tha had been performed on an unspecified date, the patient experienced a suspected infection.A revision surgery was performed to confirm / rule out the infection on (b)(6) 2021.Upon dislocation of the hip, the polarstem stem standard 3 cemented pulled right out.The device, used in treatment, was not returned for evaluation.Only a picture was provided which confirms that the stem was explanted.However, based on the available information, the relationship between the reported event and the device cannot be confirmed.The production documentation as well as a batch specific complaint history review could not be performed, since no batch number was communicated.According to ifu lit.No.12.23, ed.03/21, loosening of implant not related to bone-ingrowth is listed among potential medical device problems.The risk is in line with the current risk management file.Review of past corrective actions was performed.No further escalation is required.A medical investigation could no be performed, since the provided picture does not aid the investigation.The root cause of this issue cannot be determined.However, further investigations have shown, that the reported loosening might be related to the bone cement rather than the implant.To date, further investigations are not deemed necessary.Should the device be returned or any other information become available, this complaint will be reopened.Smith and nephew will monitor this device for further similar issues.

• Brand Name: POLARSTEM STEM STANDARD 3 CEMENTED
• 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: 13204826
• Report Number: 9613369-2022-00003
• Device Sequence Number: 4563859
• Product Code: LZO
• UDI-Device Identifier: 07611996096705
• UDI-Public: 07611996096705
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2022

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: 75002114
• Device Catalogue Number: 75002114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 12/22/2021; 02/21/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 01/27/2022; 02/22/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown