MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Model Number 04.402.007S

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Patient identifier reported as (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review was completed.Manufacturing location: supplier - (b)(4), packaged and released by: (b)(4).Manufacturing date: 30-mar-2015.Expiration date: 28-feb-2020.Part number: 04.402.007s, 7mm ti straight radial stem 26mm ¿ sterile.Lot number: 7824334 (sterile).Lot quantity: 24.Work order traveler met all inspection acceptance criteria.Certificate of compliance received from (b)(4) dated 02-mar-2015 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, (b)(4) 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.(b)(4) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 21014, tialnbri16.00.Lot number: 7557656.Lot quantity: 3,059 lbs.Certified test report supplied (b)(4) dated 22-nov-2013 and inspection certificate supplied by (b)(4) dated 25-jun-2012 were reviewed and determined to be conforming.Lot summary report dated 12-dec-2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria 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 the investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4) ufr (b)(4).

Event Description

Customer quality unit received a user facility report (b)(4) from hospital for special surgery.Only additional and/or corrected information will be contained in this report.A copy of the user facility event report is attached.It was reported that the patient had undergone an open reduction and internal fixation of proximal ulna, radial head arthropathy and lateral collateral ligament repair for left elbow fracture and dislocation on (b)(6) 2016.The patient was seen in follow-up following recall of her implants on (b)(6) 2018 and removal of hardware was discussed due to the degree of implant loosening.The patient was experiencing increased left elbow pain with activity and at night over the past six (6) months after the follow-up check.The patient reported that the pain was sharp with twinges in her left shoulder, forearm and wrist.The patient underwent a hardware removal of left radial head and radial stem on (b)(5) 2018 due to implant loosening to prevent further degradation at the proximal radius.There was no surgical delay.There was no patient consequence.This report is for one (1) straight radial stem.This is report 2 of 2 for (b)(4).

Event Description

It was reported that the patient had undergone an open reduction and internal fixation of proximal ulna, radial head arthropathy and lateral collateral ligament repair for left elbow fracture and dislocation on (b)(6) 2016 and not on (b)(6) 2016 as reported on previous medwatch report.

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.Event: corrected date of initial surgery.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 STRAIGHT RADIAL STEM 26MM-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: 8206838
• MDR Text Key: 131761466
• Report Number: 2939274-2018-55650
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 10886982128041
• UDI-Public: (01)10886982128041
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 04.402.007S
• Device Catalogue Number: 04.402.007S
• Device Lot Number: 7824334
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68