MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; CONDYLAR PLATE FIXATION IMPLANT

Model Number 02.124.413

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: patient sustained periprosthetic fracture (ppf) below femoral nail in (b)(6) and was fixed with va condylar plate on an unknown date in (b)(6) 2022.Patient was readmitted approximately 3 months after implant with plate fracture.No new trauma.Had been mobilizing in residential home.Normal to low bmi.Fracture non-united, but no evidence of infection.Revision occurred (b)(6) 2022.This is report 1 of 11 for (b)(4).This report is for a va-lcp condylar plate.This complaint is linked to (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Unknown between march 2022 and june 2022.Implant date unknown date in march 2022.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.Investigation summary: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the va-lcp condylar plate 4.5/5.0 le 12ho l2 had broken at the middle shaft section.X-ray evidence provided shows a plate and screw construct at the left distal femur with signs of bone and plate breakage.No other issues were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the va-lcp condylar plate 4.5/5.0 le 12ho l2.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history: product code: 02.124.413s, lot number: 374p884, manufacturing site: mezzovico, release to warehouse date: 05 oct 2021, expiration date: 01 sept 2031.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformance's were identified.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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15074845
• MDR Text Key: 296310762
• Report Number: 8030965-2022-05036
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: 02.124.413
• Device Catalogue Number: 02.124.413S
• Device Lot Number: 374P884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CERCL-CABLE W/CRIMP Ø1.7 SST; CERCL-CABLE W/CRIMP Ø1.7 SST; LOCKING ATTACHMENT PLATE 3.5 F/LCP 4.5/5; VA LOCKSCR Ø5 SELF-TAP L36 SST; VA LOCKSCR Ø5 SELF-TAP L38 SST; VA LOCKSCR Ø5 SELF-TAP L60 SST; VA LOCKSCR Ø5 SELF-TAP L65 SST; VA LOCKSCR Ø5 SELF-TAP L75 SST; VA PERIPROSTHETIC LOCK SCREW Ø5 SELF-TAP
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female