MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 8X28MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Tissue Damage (2104); Joint Dislocation (2374); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); No Code Available (3191)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 11-210023 703210 explor 12x20mm implant head.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02821.

Event Description

It was reported patient has been indicated for revision due to loosening; however, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records and x-rays received.Review of the available medical records identified dislocation of the head after implantation of a left radial head prosthesis.Painful limitation of movement.Large effusion was noted, no sign of infection.Rom 0-10-95°.Cartilage damage noted, head found to be dislocated, locked screw dislocated mediodorsally in the joint.Screw removed, radial head replaced, radial stem left intact.No intraop complications.Post revision radiographs demonstrate a radial head replacement with anatomic alignment and no evidence of implant failure.Pre radiographs demonstrate a displaced screw overlying the level of the proximal ulna.There is no fracture.There appears to be some radiolucency reflecting interval osteolysis along the more proximal aspect of the radial implant and there is interval development of malalignment and partial disassociation of the radial implant head-stem junction.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Event Description

It was reported patient underwent initial left elbow arthroplasty.Subsequently, the patient was revised approximately 5 years post implantation due to pain and limited range of motion.Upon revision, it was noted that the radial head was dislocated with the locking screw free floating in the joint space.The radial head and locking screw were replaced without complication.The radial stem remained intact.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

Reported event was confirmed by review of medical records and x-rays received.Review of the available medical records identified dislocation of the head after implantation of a left radial head prosthesis.Painful limitation of movement.Large effusion was noted, no sign of infection.Rom 0-10-95°.Cartilage damage noted, head found to be dislocated, locked screw dislocated mediodorsally in the joint.Screw removed, radial head replaced, radial stem left intact.No intraop complications.Post revision radiographs demonstrate a radial head replacement with anatomic alignment and no evidence of implant failure.Pre radiographs demonstrate a displaced screw overlying the level of the proximal ulna.There is no fracture.There appears to be some radiolucency reflecting interval osteolysis along the more proximal aspect of the radial implant and there is interval development of malalignment and partial disassociation of the radial implant head-stem junction.Visual examination of the returned product identified the screw threads have debris in them but there is not visible damage.The head has visible wear as the lot has worn off but not visible damage.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10300034
• MDR Text Key: 199985342
• Report Number: 0001825034-2020-02820
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-210063
• Device Lot Number: 028850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention