MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN CHS COMPRESSION HIP SCREW; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Date 05/01/2000

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Doi: 10.1097/01241398-200005000-00013.

Event Description

It was reported that, on the literature review "which implant for proximal femoral osteotomy in children?.A comparison of the ao (asif) 90[degrees] fixed-angle blade plate and the richards intermediate hip screw", one (1) patient suffered from a painful non-union, after a primary osteotomy was performed, using the compression hip screw system.The fixation system was revised with blade plate fixation 6 months after.The patient suffered from a deep infection after that, but the outcome is unknown.No further information is available.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to report painful non-union.Per the literature review, no further information is available.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The impact to the patient beyond the reported painful non-union, the revision and the deep infection cannot be confirmed no concluded due to the limited information provided.Should any additional relevant medical information be provided, this case would be re-assessed.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, excessive pressure on the joint, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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: UNKN CHS COMPRESSION HIP SCREW
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 15674695
• MDR Text Key: 302435374
• Report Number: 1020279-2022-04568
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female