MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI CURVED RADIAL STEM 42MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER

Model Number 04.402.027S

Device Problems Device Slipped (1584); Unintended Movement (3026)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown date in 2019.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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

It was reported that on (b)(6) 2015, the patient underwent a left elbow radial head prosthetic placement to treat a closed fracture of head of radius.Reportedly, on (b)(6) 2015, the patient fell from a deck approximately 5 feet directly on a concrete and sustained a radial head fracture.She had initial ct scan and left elbow xray done at (b)(6).Patient presents with a posterior splint in place with persistent moderate discomfort.Following the surgery, the patient had undergone physical therapy from (b)(6) 2015, as well as the use of a dynamic brace.On (b)(6) 2015, patient underwent a procedure for left elbow arthroscopy with capsular release and manipulation due to stiffness and in an attempt to get her back to a functional range of motion.The patient tolerated the procedure well, there were no complications, taken from the operating room in stable condition.She had an intraarticular left elbow steroid injection on (b)(6) 2016 which alleviates her pain for 1 to 2 months and a dynamic extension brace.On (b)(6) 2016, patient visited a chiropractic clinic wherein palpitation reveals areas of spasm, hypomobility and endpoint tenderness indicative of subluxation at left c2, left c3, right c5, right c6, left t2, left t3, left t4, right t6, right t7, right t8, left l4 and left l5.Post-operatively, the patient had progressing elbow discomfort, particularly on the left lateral side and notices some clinking.On (b)(6) 2017, the patient underwent a removal of left radial head arthroplasty and lateral ulnar collateral ligament reconstruction.She presented with left elbow pain, osteolysis and loosening around her radial head as well as significant erosion of her capitellum and a 45-degree flexion contracture.During her visit on (b)(6) 2017, the patient expressed a significant improvement after the surgery and is now able to lay down or sleep on her left side without major discomfort.Radiograph showed all in all good alignment of the elbow.However, on (b)(6) 2018, patient had an x-ray of her left elbow which shows small bone fragments in the operative bed, old fracture of the coronoid process, degenerative arthritis of left elbow and decreasing elbow effusion since (b)(6) 2017.This report is for one (1) 7 mm ti curved radial stem 42 mm-sterile this is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot manufacturing location: supplier - avalign nemcomed / inspected, packaged and released by monument manufacturing date: nov 26, 2014, expiration date: oct 31, 2019, part number: 04.402.027s, 7mm ti curved radial stem 42mm ¿ sterile, lot number: 7785170 (sterile), lot quantity: 48.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from alalign dated 07-nov-2014 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn 10800 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21069, tialnbri18.00 lot number: 6436951 lot quantity: 5,190 lbs.Product traveler met all inspection acceptance criteria.Certified test report supplied by perryman company dated sep 11, 2009 and inspection certificate supplied by vsmpo dated 20-feb 20, 2007 were reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review sep 24, 2019: dhr reviewed this lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: investigation summary : product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot.Manufacturing location: supplier - (b)(4) , packaged and released by: monument, manufacturing date: nov 26, 2014, expiration date: oct 31, 2019, part number: 04.402.027s, 7mm ti curved radial stem 42mm ¿ sterile, lot number: 7785170 (sterile), lot quantity: 48.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from alalign dated 07-nov-2014 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, ns050780 rev b met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev a was reviewed and determined to be conforming.Packaging bom was reviewed and found to be conforming with no deviations to normal packaging identified.Scn 10800 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: 21069, tialnbri18.00, lot number: 6436951, lot quantity: 5,190 lbs.Product traveler met all inspection acceptance criteria.Certified test report supplied by perryman company dated sep 11, 2009 and inspection certificate supplied by vsmpo dated 20-feb 20, 2007 were reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review.Sep 24, 2019: dhr reviewed.This lot met all dimensional, visual, sterility and packaging criteria with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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

No implants shown in the images received.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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: 7MM TI CURVED RADIAL STEM 42MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL , POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9134819
• MDR Text Key: 160855114
• Report Number: 2939274-2019-61040
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128096
• UDI-Public: (01)10886982128096
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 04.402.027S
• Device Catalogue Number: 04.402.027S
• Device Lot Number: 7785170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 100