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

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Arthritis (1723); Pain (1994); Loss of Range of Motion (2032)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the pegged glenoid got loose after seven years.A revision surgery will be necessary.Update on 23-dec-2020: initial surgery took place on (b)(6) 2013.Surgery report indication: patient had pain in the right shoulder for about three to four years with only some limited movement.The apron grip in particular is increasingly limited.The examinations including an arthro mri from (b)(6) 2012 revealed a pronounced omarthrosis (shoulder arthrosis) with a slap lesion at a high level.The humeral head is progressively subluxating dorsally.The indication for shoulder arthroplasty is clear.Revision surgery took place on (b)(6) 2020.Part number of the glenoid is ar-9105-0x.

Manufacturer Narrative

Complaint confirmed, the glenoid poly was explanted but not returned.Pictures provided show the device had a broken central peg, damaged/cracked edges and inferior side.Bone and/or bone cement residue were observed on the inferior side.The cause of the event is however undetermined.

• Brand Name: UNK
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11146678
• MDR Text Key: 226017207
• Report Number: 1220246-2021-02460
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 06/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other