MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BASIS 12/14 TPR PRI CLLD SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71312262
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a thr surgery performed in 2019, the patient reported pain and hasn't been able to walk.After taking x-rays it was identified that the basis 12/14 tpr pri clld sz 2 was fractured around 2 cm from the tip of the implant distally.A revision surgery is recommended by the physician but the patient refuses to do it.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device was not returned for evaluation but the reported event could be confirmed with the clinical/medical findings.The clinical/medical investigation concluded that, patient had a total hip replacement in 2019, and has reported pain and inability to walk.It was reported x-rays identified that the basis 12/14 tpr pri clld sz 2 was fractured around 2 cm from the tip of the implant distally.The provided x-rays were reviewed and show radiolucencies around the bone cement and osteolytic changes around the proximal femur which could indicate loosening.We confirm the reported implant breakage.No additional clinical documentation was provided.We cannot assess a clinical root cause with the limited information provided, but micromotion and a resulting fatigue fracture cannot be ruled out.A revision surgery is recommended by the physician but the patient refuses to do it.The patient impact beyond the reported events cannot be determined.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for hip systems revealed that cracking or fracture of implant components, may lead to revision surgery, besides, implant can break or become damaged as a result of strenuous activity or trauma, this has been identified in possible adverse effects, warnings and precautions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.Raw material is checked against the drawing in incoming inspection, where also a batch number is assigned to the material.The stamp on the certificate confirms that the material was checked against material specification.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury or abnormal loading of the limb.The contribution of the device to the reported incident could be corroborated as the device was broken and it is required a revision surgery.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: BASIS 12/14 TPR PRI CLLD SZ 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15715006
• Report Number: 1020279-2022-04644
• Device Sequence Number: 15103552
• Product Code: JDI
• UDI-Device Identifier: 03596010412911
• UDI-Public: 03596010412911
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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 Expiration Date: 12/28/2025
• Device Model Number: 71312262
• Device Catalogue Number: 71312262
• Device Lot Number: 15MT62938
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2015
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown