MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 16X22MM IMPLANT HEAD; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Catalog Number 11-210034

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Discomfort (2330)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reporter has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated products and reports.0001825034-2023-01076 item#11-210063; lot#254380.

Event Description

It was reported a patient underwent a left elbow procedure.Subsequently, the patient developed moderate stiffness and limited extension.The patient required reoperation to excise thick scar tissue on the anterior aspect of the joint and ossification excision was also performed.The patient has continued to experience mild pain for which additional consultation is ongoing.However, components remain in place.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed annex g code: mechanical (g04) - head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: initial surgery: l primary radial head arthroplasty procedure, no complications noted, patient tolerated the procedure well and left the or in stable condition.3 months postop; onset of moderate stiffness in the l elbow with limited extension noted.4 months post op; reoperation of affected joint, scar tissue and ossification excised.14 months postop: mild pain noted, injection given, patient remains in study 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: EXPLOR 16X22MM IMPLANT HEAD
• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16947506
• MDR Text Key: 315402562
• Report Number: 0001825034-2023-01077
• Device Sequence Number: 1
• Product Code: KWI
• UDI-Device Identifier: 00880304210400
• UDI-Public: (01)00880304210400(17)290128(10)238890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11-210034
• Device Lot Number: 238890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 71 KG