MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RAD HEAD 22 UNCEM H14.5 W/EXT 2 TAN/COC; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.222S

Device Problem Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown radial head/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.Reporter is an attorney.(b)(4).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

It was reported that patient who is now more than 1 year out from left radial head replacement arthroplasty.Returned stating that while picking up a (b)(6) year-old granddaughter, patient felt a snap within the arm and had pain.Patient was seen at an urgent care facility and told that she had a periprosthetic fracture around her old radial head replacement.X-ray reviewed on (b)(6) 2017 revealed that the patient's left elbow show evidence of periprosthetic osteolysis and perprosthetic fracture involving the proximal radial shaft.Ct scan reviewed on (b)(6) 2018 revealed significant bony remodeling of the proximal radial shaft in the area surrounding the radial head implant with an adjacent perprosthetic fracture at the tip of the implant.The patient's bicipital tuberosity appeared to be entirely located on the proximal fracture fragment.There is cortical thinning as well as bony remodeling.X-ray reviewed on (b)(6) 2018 revealed that on the left elbow, three views, demonstrate again congruent well-reduced ulnohumeral joint line, normally aligned radiocapitellar joint, however with radial head replacement arthroplasty, significant proximal osteolysis, loosening of the implant, cortical thinning, and mild intramedullary expansion with remodeling compared to prior imaging.Concomitant device reported: radial stem (part # unknown, lot # unknown, quantity 1) this report is for one (1) unknown radial head prosthesis.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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/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.H3, h4, h6: device history lot manufacturing location: supplier - (b)(4), packaged and released by: monument, release to warehouse date: 17-jul-2012, expiration date: 30-jun-2017, part number: 09.402.222s, 22mm cocr radial head 2mm ht extension/14.5mm ¿ sterile, lot number: 6892425 (sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Certificate of compliance received from avalign dated 06-jun-2012 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, (b)(4) rev a 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 8600 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: 21022, tialnbri8.00, lot number: 5317556, lot quantity: (b)(4).Product traveler met all inspection acceptance criteria.Raw material inspection sheet, met all inspection acceptance criteria.Product certification supplied by dynamet dated 27-sep-2006 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 41046, cocrmori47.63, lot number: 6150723, lot quantity: (b)(4).Product traveler met all inspection acceptance criteria.Certificate of tests supplied by (b)(4) dated 31-jul-2008 was reviewed and determined to be conforming.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review 03-nov-2020: 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b6, b7 d6a 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: RAD HEAD 22 UNCEM H14.5 W/EXT 2 TAN/COC
• 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: 10639248
• MDR Text Key: 212849631
• Report Number: 2939274-2020-04537
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 09.402.222S
• Device Lot Number: 6892425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Treatment: UNK - RADIAL HEAD PROSTHESIS; UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM; UNK - RADIAL HEAD PROSTHESIS: RADIAL STEM
• Patient Outcome(s): Required Intervention
• Patient Weight: 60