MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOM XL 44-36 STD HMRL BRNG; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 115313, comp rvsr shldr glnsp +3 36mm, 378610; 113609, comp primary stem 9mm micro, 919730; 115396, comp rvs cntrl 6.5x30mm st/rst, 046620; 115370, comp rvs tray co 44mm, 083400; 180550, comp lk scr 3.5hex 4.75x15 st, 280260; 180556, comp lk scr 3.5hex 4.75x45 st, 186540; 180554, comp lk scr 3.5hex 4.75x35 st, 541870; 010000589, comp rvrs 25mm bsplt ha+adptr, 563340.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 - 00199, 0001825034 - 2018 - 00200, 0001825034 - 2018 - 00201, 0001825034 - 2018 - 00202, 0001825034 - 2018 - 00203, 0001825034 - 2018 - 00204, 0001825034 - 2018 - 00205, 0001825034 - 2018 - 00198.Remains implanted.

Event Description

It was reported that the patient underwent reverse shoulder replacement on an unknown date.Subsequently, the patient is experiencing pain and a possible allergic reaction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.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.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• 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: 7188881
• MDR Text Key: 97298008
• Report Number: 0001825034-2018-00206
• 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: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/26/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 963740
• Other Device ID Number: (01) 00880304475427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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): Other