MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOM XL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).Comcomitant products: comprehensive reverse shoulder glenosphere std 36mm pn: 115310 ln:969190.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.

Event Description

It was reported that patient underwent initial right reverse total shoulder replacement.Subsequently, the patient was revised due to dislocation.

Manufacturer Narrative

(b)(4).Concomitant medical products: comp lk scr 3.5hex 4.75x30 st, lot#820860, item#180553, comp lk scr 3.5hex 4.75x25 st, lot#039010, item# 180552, comp lk scr 3.5hex 4.75x15 st, lot#820680 item#180550, comp lk scr 3.5hex 4.75x15 st, lot#850920, item#180550, comp rvs cntrl 6.5x35mm st/rst, lot#430520, item#115397, comp rvs tray co 44mm, lot#951720, item#115370, comp rvrs 25mm bsplt ha+adptr, lot#793530, item#010000589, comp primary stem 9mm std, lot#153780, item#113649.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Compatibility check noted no issues.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOM XL
• 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: 7014798
• MDR Text Key: 91514393
• Report Number: 0001825034-2017-10071
• 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: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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: 07/22/2020
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 599600
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2015
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention