MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIGLIANI/FLATOW MODULAR HUMERAL STEM 13 MM DIAMETER 130 MM LENGTH; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Reaction (2414); Cognitive Changes (2551); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation; product location 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: 0001822565-2018-03176.

Event Description

It was reported that the patient underwent a left shoulder revision surgery approximately thirteen (13) years post-implantation due to alleged possible cobalt toxicity and lack of range of motion.Patient began experiencing symptoms approximately two to three (2-3) years prior to the revision procedure.The patient was revised to a titanium implant.

Manufacturer Narrative

The complaint is confirmed based in the surgical op noted and medical records that were provided.Device history records were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.A definitive root cause cannot be identified based on the information provided.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: BIGLIANI/FLATOW MODULAR HUMERAL STEM 13 MM DIAMETER 130 MM LENGTH
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7593985
• MDR Text Key: 110843890
• Report Number: 0001822565-2018-03177
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: PK982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2014
• Device Model Number: N/A
• Device Catalogue Number: 00430001313
• Device Lot Number: 60132791
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00430205218 OFFSET MODULAR 60214439
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 136