MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	75004650
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, when the the stem was being implanted, the positioner was hammered and when the stem was going to be released, the nut of the polarstem stem inserter got stuck and would not release, it was necessary to make several maneuvers until it was released but the stem nut fell off.Also, the polarcup head/liner inserter, when assembled, had a kind of misalignment that did not seem normal.The surgery was completed, without any delay, with the same reported devices.The patient's health was not affected.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: it was reported that, during a total hip replacement surgery, when the stem was being implanted, the positioner was hammered and when the stem was going to be released, the nut got stuck and would not release, it was necessary to make several maneuvers until it was released but the stem nut fell off, the press when assembled had a kind of misalignment that did not seem normal.The patient's health was not affected.The complaint device was not returned for investigation.A product evaluation was not possible.No batch number was communicated, so a review of the production records was not possible.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.The root cause of the reported event can be attributed to problems traced to the intentional use of the device in way which it is contraindicated.The relevant surgical technique, 01217-en_v5 09/17, illustrates in detail, that "cemented stems are made of stainless steel and have restrictions on material combinations (see page 5).The stem inserter (75004650/21000300) is intended to be used for cemented stems only and shouldn¿t be used for impaction of ti/ha stems.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: POLARSTEM STEM INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 20418039
• Report Number: 9613369-2024-00135
• Device Sequence Number: 8589784
• Product Code: LXH
• UDI-Device Identifier: 07611996097573
• UDI-Public: 07611996097573
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 75004650
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 85 KG