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

Model Number	71335548
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post-market clinical follow-up activity that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
On the pmcf titled dca-1000 accord ss clinical dataset, it was reported that, after undergoing left tha, one (1) patient experienced unspecified events that led to a revision surgery combined with internal fixation.This surgery was performed on (b)(6) 2021, in which an intraoperative femur fracture occurred.As remedial action, an accord cable system was implanted.A post-operative follow-up confirmed a good position without complicating features.
Additional Manufacturer Narrative
Correction: (b)(4).Initial complaint was created against r3 3 hole acet shell mm48; a case re-assessment determined that, since a femur fracture occurred, complaint must be against the femoral stem.Corrected data: d1/d2a/d2b: brand name, product code.D3: manufacturer name, city and state.D4: catalog number, lot number, expiration date, udi.D10: concomitant medical products.Contact office: manufacturing site.G3 / g4: pma/510(k)number.H4: device manufacture date.

• Brand Name: POLARSTEM COLLAR STANDARD TI/HA 3 (US)
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau TN ; SZ
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16583202
• Report Number: 1020279-2023-00605
• Device Sequence Number: 4694441
• Product Code: LZO
• UDI-Device Identifier: 00885556533611
• UDI-Public: 885556533611
• 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
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023
• 2 Devices were Involved in the Event: 1 2

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: 08/29/2022
• Device Model Number: 71335548
• Device Catalogue Number: 75102253
• Device Lot Number: B1509706
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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: OX FM HD 12/14TPR 32MM+4(PN:71343204,LN:19LM14107); PLRSTM CLLR STNDRD TI/HA3(PN:75102253,LN:B1509706); R3 3H ACT SHLL48MM(PN:71335548,LN:19JM15000); R3 ACET LNR 32X48MM(PN:71337648,LN:14LM07977); RFLCTN SPH HD SCRW35MM(PN:71332535,LN:20KB00446)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female