MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN CHS COMPRESSION HIP SCREW PLATE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number UNKNOWN

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

Patient Problems Pain (1994); Discomfort (2330)

Event Date 10/09/1988

Event Type  Injury  

Event Description

It was reported that on literature review "unstable intertrochanteric fractures of the hip: treatment with ender pins compared with a compression hip-screw.", three (3) patients who underwent primary implantation with a compression hip screw + plate for treatment of unstable intertrochanteric fractures required the removal of the implants due to postoperative pain.The postoperative period during which these interventions were performed and the identity of the explanted devices are not known.No further information is available.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).Ingemar sernbo, olof johnell, carl-frederik gentz, jan-aake nilsson.(1998).Unstable intertrochanteric fractures of the hip: treatment with ender pins compared with a compression hip-screw.The journal of bone and joint surgery.

Manufacturer Narrative

Section h10: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the article noted three (3) patients required removal of the implants due to postoperative pain; however, the timeframe during which these interventions were performed and the specific explanted components are not known.Reportedly, there is no contact information available for this literature case; therefore, patient specific supporting documentation or current patient status has not been provided as of the date of this medical investigation.The images provided in the article have been interpreted within the text; therefore, no further analysis of the imaging is required.The clinical root cause of the reported events cannot not be further assessed.The patient¿s outcome beyond that which was documented in the article cannot not be determined as the patient¿s current health status remains unknown.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors that could contribute include but are not limited to traumatic injury and/or joint tightness.The contribution of the devices 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 products involved, our investigation could not proceed.Should the devices 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.Internal complaint reference number: (b)(4) section h6 (clinical code) was corrected.

• Brand Name: UNKN CHS COMPRESSION HIP SCREW PLATE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 14831767
• MDR Text Key: 294872364
• Report Number: 1020279-2022-03127
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other