MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD 23 MM HEAD HEIGHT 46 MM; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Muscle/Tendon Damage (4532)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 00434811513 - humeral stem 48 degrees 15 mm stem diameter 130 mm stem length - 61217924; 00432605246 - trabecular metal glenoid component 46 mm articular surface use with blue instruments & white humeral head - 61262424.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03238.

Event Description

It was reported that a patient underwent an initial left shoulder arthroplasty.Approximately 9 years post implantation, the patient was revised due to pain in the shoulder and surrounding regions, loss of range of motion, instability, rotator cuff failure and component dissociation.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause could not 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 further event information available at the time of this report.

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.Updated: a4, a5, b4, b5, b7, e1, e2, e3, g2, g3, h2, h6.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.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records identified the following: progressive pain and difficulty with use over last several years.Dislocation with adl¿s on a routine basis with pain and instability.Indications note well osseous integrated stem, osteopenia, loose beads proximally consistent with possible metallosis.Stem was then extracted without difficulty, and poly was worn and removed.Tantalum was drilled through for placement of a glenoid base plate.Encore djo reverse system was done.Complete rupture of rotator cuff noted as well as mechanical complication and failure of internal orthopedic device noted on diagnosis.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.

• Brand Name: OFFSET MODULAR HUMERAL HEAD 23 MM HEAD HEIGHT 46 MM
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10523331
• MDR Text Key: 206735471
• Report Number: 0001822565-2020-03237
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00430204623
• Device Lot Number: 61235446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White