MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

510k.This report is for an unknown pfna construct unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: yu w., et al (2020)conversion from a failed proximal femoral nail anti-rotation to a cemented or uncemented total hip arthroplasty device: a retrospective review of 198 hips with previous intertrochanteric femur fractures, bmc musculoskeletal disorders volume 21, pages 1-9 (china) this study aims to execute a retrospective review to assess clinical outcomes of this conversion of a failed pfna to either a dual-uncemented uta or a dual-cemented cta device without antibiotics in the elderly population with primary iffs.March 1, 2007 to march 31 2017, 258 consecutive elderly individuals with iffs who had experienced a conversion from a failed pfna to a dual-uncemented uta device or a dual -cemented cta device were identified and analyzed.Among these patients 60 did not meet the criteria for inclusion, leaving 198 patients eligible for the study.These patients were divided into groups : the group uta(n=98) with 45 males, 53 females and the group cta (n=100) with 48 males, 52 females.The mean age at the time of the revision was 66 (62¿71) years for a uta device and 66 (61¿71) years for a cta device.The median follow-up was 65 (60¿69) months for the uta group and 65 (61¿69) months for the cta group.The following complications were reported as follows: -258 patients with a failed pfna were identified.(60 of whom did not meet the criteria for inclusion).Instability 23 for uta group and 25 for cta group.(reasons for conversion from a failed pfna) mechanical failure 22 for uta group and 23 for cta group.(reasons for conversion from a failed pfna) instability and mechanical failure 53 for uta group and 52 for cta group.(reasons for conversion from a failed pfna) this report is for an unknown synthes pfna construct.It captures mechanical failure of 22 for uta group and 23 for cta group.(reasons for conversion from a failed pfna) a copy of the literature article is being submitted with this medwatch.This is report 2 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11426000
• MDR Text Key: 246996497
• Report Number: 8030965-2021-01678
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention