MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ELBOW RADIAL; ELBOW PROSTHESIS/EXTREMITIES

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Noise, Audible (3273); Migration (4003)

Patient Problems Subluxation (4525); Joint Laxity (4526)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: item#: unknown, unknown stem; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the underwent an initial left elbow arthroplasty on an unknown date.Subsequently, the patient underwent a revision surgery due to implant subluxation.No additional information is available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: 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

It was reported that the patient underwent an initial left elbow arthroplasty on and unknown date.Subsequently, the patient underwent a revision surgery approximately 2 (2) and half years ago due to subluxation, popping, and noise.During the revision the surgeon noted that the implant was to large for the patient and a smaller implant was implanted.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: component codes: mechanical (g04) - head no product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: november 4th 2020: popping and instability, previous incisions utilized, lateral ulnar collateral ligament insufficiency noted and radial head was too big for this patient and downsized to a small, stem well fixed, intraoperative x-rays: instability due to ligament insufficiency, palmaris longus harvested to repair ligament insufficiency.A definitive root cause cannot 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.

• Brand Name: UNKNOWN ELBOW RADIAL
• Type of Device: ELBOW PROSTHESIS/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16781727
• MDR Text Key: 313706459
• Report Number: 0001822565-2023-01085
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 124 KG