MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN CHS COMPRESSION HIP SCREW PLATE; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLY

Catalog Number UNKN02200502

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

Patient Problem Necrosis (1971)

Event Date 12/01/1995

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On the literature review "fixation of femoral neck fracture: a randomized 2-year follow-up study of hook pins and sliding screw plate in 222 patients", it was reported that fourteen (14) patients who underwent primary implantation with a sliding screw and plate to treat a cervical hip fracture, experienced a postoperative femoral head collapse.From these, four (4) underwent revision surgery to implant an unspecified endoprosthesis in exchange.The outcome of these patients is not known.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Section h10: the devices were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that, per the complaint, no further information is available.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patients outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, 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 and/or potential causes that could contribute to the reported events include excessive forces applied to implant and patients condition.The contribution of the devices to the reported events 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) ection h6 (impact code) was corrected.

• Brand Name: UNKN CHS COMPRESSION HIP SCREW PLATE
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLY
• 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: 14853309
• MDR Text Key: 294927770
• Report Number: 1020279-2022-03163
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02200502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other