MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE E1 RETENTIVE +3 MM HUMERAL BEARING; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Scar Tissue (2060); Joint Dislocation (2374)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: comprehensive humeral tray 44 mm x 5 mm, [115375; lot 070520]; versa-dial glenosphere standard 36 mm, [115310; lot 247930]; central screw 6.5 mm 3.5 hex 30 mm length, [115396; lot 492050]; fixed locking screw 4.75 mm 3.5 hex 30 mm length, [180553; lot 642760]; fixed locking screw 4.75 mm 3.5 hex 35 mm length, [180554; lot 135720]; comprehensive mini baseplate and taper adaptor 25 mm, [010000589; lot 082010]; fixed locking screw, [180550; lot 808750]; fixed locking screw, [180550; lot 084440].Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034 - 2018 - 05106, 0001825034 - 2018 - 05163, 0001825034 - 2018 - 05164.

Event Description

It was reported the patient underwent a possible closed reduction procedure of a reverse total shoulder arthroplasty approximately one (1) month post-operatively due to dislocation.Subsequently, the patient underwent a revision procedure approximately two (2) months post-operatively due to humeral stem subsidence/migration.Patient also had comminuted humeral bone that was removed.A larger humeral tray and bearing were also implanted.

Manufacturer Narrative

(b)(4).Concomitant medical products- fixed locking screw [180550; lot 084440] qty: 2, comp primary stem 8mm mini [part #113628 lot # 095780 ].Reported event was confirmed by review of operative notes and x-rays provided.The humeral component had subsided and rotated 180 degrees per x-rays.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined however, it is noted that the patient was a tobacco user, had poor nutrition and health issues, was noncompliant and had multiple falls on her left shoulder which may have contributed to the reported events.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: COMPREHENSIVE E1 RETENTIVE +3 MM HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7785154
• MDR Text Key: 117187815
• Report Number: 0001825034-2018-05107
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK113121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-115395
• Device Lot Number: 253370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2019
• 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: 51 YR