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

Catalog Number	11-210063
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4), multiple mdr reports were filed for this event.Please see the associated report: 0001825034-2023-02189.D10: unknown explor head, lot unknown.The customer 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.A supplemental will be filed accordingly if any further information is found that would change or alter any conclusions or information.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported the patient underwent a left arm procedure approximately six (6) years ago.The patient is now reported to be experiencing extreme pain.However, no revision procedure or further intervention has been reported to date.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: item# 11-210032; lot# 034410.If any further information 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 or Problem Description
It was reported that the patient underwent a trauma procedure approximately six (6) years and four (4) months ago following a fall that fractured the left ulnar and radial head of the humerus.Subsequently, the patient began experiencing pain, decreased rom, swelling and noise approximately five (5) years and six (6) months post-implantation.X-ray images were taken approximately six (6) months ago and revealed radial head had disassociated from stem and progression of arthritis was noted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2023 xray progressed arthritis, effusion, dissociation (disengaged) of radial head from radial prosthesis.Xray notes good alignment of ulna.Left elbow pain 7/10, swelling pain, decreased rom, symptoms begun (b)(6) 2022.No trauma, pain with rotation of arm and clicking.Discussed plan : will need revision surgery and will call when he wants surgery.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information 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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b2; b3, b4; b5; d2; d6b; g1; g3; g6; h1; h2; h6.If any further information 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 or Problem Description
It was reported that the patient underwent a trauma procedure approximately seven (7) years ago following a fall that fractured the left ulnar and radial head of the humerus.Subsequently, the patient began experiencing pain, decreased rom, swelling and noise approximately five (5) years and six (6) months post-implantation.X-ray images were taken and revealed the radial head had disassociated from stem and progression of arthritis was noted.The patient later underwent a revision surgery approximately four (4) months ago.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 the root cause of the previous investigation remains as cannot be determined.If any further information 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Common Device Name: 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: 17795189
• Report Number: 0001825034-2023-02190
• Device Sequence Number: 17887892
• Product Code: KWI
• UDI-Device Identifier: 00880304210462
• UDI-Public: (01)00880304210462(17)260308(10)209490
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2026
• Device Catalogue Number: 11-210063
• Device Lot Number: 209490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 10/10/2023; 02/08/2024; 06/21/2024; 09/16/2024
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/31/2023; 02/09/2024; 07/15/2024; 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.; SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White