MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.008S

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Date of event: unknown.This report is for an unknown radial stem/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a lawyer.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent removal of the radial head prosthesis system from the right arm on (b)(6) 2016, due to postoperative loosening at the stem bone interface.The original implant date was (b)(6) 2016.Concomitant devices reported: unknown radial head (part/lot unknown, quantity 1).This report is for an unknown radial stem.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product code, lot#, expiration date and udi# ;part# and lot# of concomitant device.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 further reported that:patient sustained a comminuted right radial head fracture after a fall off a bicycle on (b)(6) 2016.As the patient had three pieces of radial head which had minimal connection back to the proximal radius, the patient was implanted with a total radial head and stem with an uncemented radial head arthroplasty on (b)(6) 2016.A post-operative x-rays taken on (b)(6) 2016 showed lucency about the stem of the component suggesting loosening at the stem bone interface.This resulted in osteolysis around the proximal humerus and the patient had associated right forearm pain.For this reason x-rays of the forearm and wrist were ordered as well as an mri (magnetic resonance imaging) of the forearm to rule out an interosseous membrane or medial collateral ligament injury (foreshortening of the radius).The patient had reported wrist pain that became resolved but also of radial-sided forearm pain.The patient underwent removal of the radial head prosthesis system from the right arm on (b)(6) 2016.Since the removal of the implants, the patient has been experiencing lateral sided pain around the lateral condyle of the distal humerus.Occasionally, the patient has some medial-sided pain about the elbow described as a shooting pain and occasional numbness that will go into the fourth and fifth digits of the hand.The pain is reportedly worse at night of when the elbow is bent for a prolonged period of time as well as when the patient grips tightly or tires to open or when she has to push her hands together or close a heavy door.The pain limits more intense activities but day-to-day use of the arm without heavy lifting causes only mild soreness.Patient also reports fatigue and right wrist pain described as overall soreness.Post-explant x-rays taken on or about (b)(6) 2018 shows about 2mm of radial shortening.Patient at this time was noted to have a full range of motion, proximal radial ulnar impingement with crepitus and a clunk while compressing that did not increase symptoms.On (b)(6) 2016 the patient reported the numbness and tingling of the hands was later reportedly no longer present and that the radial-sided forearm pain is much improved.In general the patient reported that the overall feeling in the elbow is essentially back to normal.Primary complaint was difficulty with pushing with that hand when trying to pack clothes in a bag or when pushing open a closed door.Patient also has an occasional feeling of a catch in the elbow when it goes from a hyper flexed to an extended position with the forearm in mid-pronosupination.That sensation happens a couple of times a day, was worse when it first started and now has been improving.It is not reproducible.Pain scale is a 1/10.Medial-sided pain of the elbow persisted the following month.Concomitant devices reported: radial head (part # 04.402.008s, lot # h044645, quantity 1).

Manufacturer Narrative

Device history records review was completed for part# 04.402.008s, lot# h044645.Manufacturing location: supplier (b)(4), packaged by: (b)(4), manufacturing date: mar 09, 2016, expiry date: feb 28, 2021.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Raw material part 21014 lot number 7557656 reviewed.Raw material provided by (b)(4).Certified test report received from (b)(4) met specification.Raw material receiving/putaway checklist met specification.Certificate of compliance from (b)(4) met specification.Packaging component reviewed and they met specification.Inspection sheet for incoming final inspection met specification.Sterility documentation was reviewed and determined to be conforming.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: 8MM TI STRAIGHT RADIAL STEM 28MM-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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7263105
• MDR Text Key: 99789964
• Report Number: 2939274-2018-50586
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 04.402.008S
• Device Lot Number: H044645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 03/15/2018
• Supplement Dates FDA Received: 03/14/2018; 03/15/2018
• Date Device Manufactured: 03/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR