MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIGLIANI FLATOW MODULAR HUMERAL STEM 11MMX130MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problems Fall (1848); Pain (1994)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00432605200, trabecular metalâ glenoid component, 62863158 00430205221, offset modular humeral head, 62788725.Foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 - 04898.Not yet returned.

Event Description

It was reported that patient had initial total shoulder arthroplasty.Subsequently, patient was revised approximately three (3) years post initial surgery due to pain and loosening.Patient had a fall one (1) year post initial surgery.Upon x-ray review post fall, glenoid loosening and lucency with intra-articular metal debris was observed.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Udi # (b)(4).Reported event was confirmed by review of the product return and x-rays.As per the visual inspection of the product, there are some scratches on the articulation surface of the head, possibly happened during explantation.The humeral stem exhibits a shiny spot on the glass bead finish.Dimensions taken are within specifications.As per the x-ray review, extensive abnormal radiolucency along the glenoid and humeral components of the left shoulder arthroplasty consistent with component loosening.Dhr was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to human factor.It is reported that, patient sustained a work-related fall may-2016.Patient returned to surgeon 10 months post fall.Upon xray review, surgeon noted lucency of the glenoid without clinical complications.Details of the fall are unknown.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.

• Brand Name: BIGLIANI FLATOW MODULAR HUMERAL STEM 11MMX130MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7855346
• MDR Text Key: 119528039
• Report Number: 0001822565-2018-04899
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: PK982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00430001113
• Device Lot Number: 62867066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 95