MAUDE Adverse Event Report: ARTHREX INC. UNIVERSAL GLENOID - BASEPLATE SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number AR-9120-01

Device Problems Break (1069); Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.If the device is returned and additional information is obtained, a follow-up report will be submitted.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.

Event Description

It was reported that the universal glenoid got loose and both peripheral screws broke.No bony ingrowth in baseplate.Patient did not suffer any injury/ fall post surgery but patient was non-compliant with regards to post-op rehab schedule.He is a hand labourer, working on trucks.This was a third surgery.The implants were removed, apart from the broken-off superior screw, which could not be retrieved.As this part was deep in the bone, it will not interfere with the humeral implant.After removal of the implants, all remaining holes in the glenoid were bone grafted, thus converting a total shoulder prosthesis to a hemi.Male, age (b)(6), weight est.(b)(6) kg.The uhmwpe inlay (b)(4) however was heavily damaged during the attempt to retrieve the part during the revision.It looked intact before the surgeon started the retrieval.When retrieved, the baseplate didn't have any bony ingrowth, so no bone was cleaned off the implant.The implant came out together with the remaining well fixed screws.The surgeon stated that the patient was non-compliant with regards to his post-op rehab scheduled and started working too soon after first and second surgery.

• Brand Name: UNIVERSAL GLENOID - BASEPLATE SMALL
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7137339
• MDR Text Key: 95453436
• Report Number: 1220246-2017-00483
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057340
• UDI-Public: 00888867057340
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: AR-9120-01
• Device Lot Number: 160056212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 90