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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown humeral head, unknown glenoid.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: 0001825034-2017-11268, 0001825034-2017-11270.

Event Description

It was reported that the patient had an initial left shoulder arthroplasty on unknown date.Subsequently, the patient has been indicated for revision due to unknown reasons.No further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.Device remains implanted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient had an initial left shoulder arthroplasty.Subsequently, the patient has been indicated for revision due to dislocation.No further information has been provided.

Manufacturer Narrative

(b)(4).Investigation results remain unchanged as previously reported on 0001825034-2017-11269-2 and root cause remains 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated to manufacturer? not returned to manufacturer.

Event Description

It was reported that the patient had an initial left shoulder arthroplasty.Subsequently, the patient was revised due to dislocation eight (8) months post initial surgery.No further information has been provided.

• Brand Name: ARCOMXL RETENTIVE +3 MM HUMERAL BEARING
• Type of Device: PROSTHESIS, SHOULDER
• 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: 7148361
• MDR Text Key: 95841032
• Report Number: 0001825034-2017-11269
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2019

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: Physician
• Device Expiration Date: 12/29/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-115365
• Device Lot Number: 418890
• Other Device ID Number: (01) 0 0880304 47551 9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 03/19/2018; 05/07/2018; 04/09/2019; 05/09/2019
• Supplement Dates FDA Received: 04/17/2018; 05/08/2018; 05/06/2019; 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other