MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR IMPLANT LOCKING SCREW; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-210033 994720 explor 14x22mm implant head, unknown schaft explor.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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 - 2019 - 05521.

Event Description

It was reported patient¿s elbow was revised approximately six months post implantation due to dislocation of the head and the locking screw.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified implant disassembly.Overall sizing of the radial head implant appears to be appropriate.No factors are identified which may have contributed to the alleged event.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

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

Event Description

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

• Brand Name: EXPLOR IMPLANT LOCKING SCREW
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9445490
• MDR Text Key: 170102964
• Report Number: 0001825034-2019-05520
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00880304210493
• UDI-Public: (01)00880304210493
• 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
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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: 11-210099
• Device Lot Number: 903300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 75