MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 7X26MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Catalog Number 11-210062

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Mfr site: foreign-(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as 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 - 2021 - 00485.Product remains implanted.

Event Description

It was reported that revision surgery is planned due to dislocation of the screw connecting the head with the stem.No additional patient consequences were reported.

Manufacturer Narrative

Cat-11-210031 lot-011660 explor 10x22mm implant head.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that revision surgery was performed approximately (22) months post initial procedure.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Medical records/radiographs were reviewed and identified the following: three sets of two views of the left elbow demonstrate a left radial head arthroplasty.On image four and six of six, the radial head arthroplasty has come loose with a screw seen within the soft tissues dorsal and radial to the arthroplasty.No fracture was seen.Overlying soft tissue swelling is present.Review of device history record (dhr) identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information is available at the time of this report.

• Brand Name: EXPLOR 7X26MM 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: 11328135
• MDR Text Key: 239567201
• Report Number: 0001825034-2021-00481
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11-210062
• Device Lot Number: 485410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10.; UNKNOWN HEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR