MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ACROM XL 44-41 STD HMRL BRNG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿.

Event Description

It was reported a patient enrolled in a clinical study underwent an initial right shoulder arthroplasty on (b)(6) 2015.Subsequently, patient underwent an incision and drainage procedure on (b)(6) 2015 due to a hematoma.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records identified that patient underwent an i&d post op due to a hematoma, and was placed on prophylactic measures.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdrs were filed for this event.Please see associated: 0001825034 - 2015 - 03711, 0001825034 - 2019 - 03545, 0001825034 - 2019 - 03546, 0001825034 - 2019 - 03547, 0001825034 - 2019 - 03548.Concomitant medical products : p/n 113631 lot 723680 (humeral stem) ; udi : (b)(4), p/n 115370 lot 059230 (humeral tray) ; udi : (b)(4), p/n xl-115366 lot 856240 (humeral bearing) ; udi : (b)(4), p/n 115323 lot 693530 (glenosphere) ; udi : (b)(4), p/n 010000589 lot 234640 (glenoid baseplate) ; udi : (b)(4), p/n 115396 lot 947670 (central screw) ; udi : (b)(4), p/n 180552 lot 575560 (locking screw) ; udi : (b)(4), p/n 180552 lot 715580 (locking screw) ; udi : (b)(4), p/n 180554 lot 565860 (locking screw) ; udi : (b)(4), p/n 180550 lot 748350 (locking screw) ; udi : (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

No further information is available at the time of this reporting.

• Brand Name: ACROM XL 44-41 STD HMRL BRNG
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 5016031
• MDR Text Key: 23516040
• Report Number: 0001825034-2015-03711
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Followup,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-115366
• Device Lot Number: 856240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2019
• 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: 59 YR
• Patient Weight: 117