MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number 75004612

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, during a thr, the connection section on a plus sl mia dbl offset adapt.Lt 60/25mm was found to be broken.Surgery was resumed, after a non-significant delay, with the same device.No patient harm has been reported.

Manufacturer Narrative

H11: this complaint has been reassessed based on additional information gathered by the manufacturer.It was determined that this event does not fulfill reporting requirements per 21 cfr §803.Based on the visual analysis findings, the part of the device that broke off corresponds to the proximal end of the adapter, which does not comes in contact with the patient.There is no chance of any broken pieces falling into the patient's incision, as the broken part is connected to the knocking plate, which will retain the broken piece in the event of a breakage as initially reported.

Manufacturer Narrative

Results of investigation: it was reported that, during a total hip replacement, the connection section on a plus sl mia dbl offset adapt.Lt 60/25mm was found to be broken.No patient harm has been reported.The device used in treatment was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the document history review was not possible.Due to an unknown batch number, the review of historical complaints was performed on product number basis only, revealing 4 additional complaints over the past 12 months with similar failure mode.Due to insufficient information it is not possible to perform a review of past corrective actions.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.The performed investigation does not lead to an accurately determined cause.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag", 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: PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: 17008449
• MDR Text Key: 316004646
• Report Number: 9613369-2023-00149
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 07611996085464
• UDI-Public: 07611996085464
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75004612
• Device Catalogue Number: 75004612
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1