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

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Therapy date - (b)(6) 2017.Comp rvs tray co 44mm, catalog # 115370, lot # 418310.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr repots were filled for this event: 0001825034 - 2017 - 06991.

Event Description

It is reported that the surgeon had difficulty inserting the bearing due to the locking ring on the humeral tray.

Manufacturer Narrative

Concomitant medical products- comp rvs tray co 44mm catalog#: 115370 lot#: 418310, comp rvrs 25mm bsplt ha+adptr catalog#: 010000589 lot#: 129050, comp rvs tray co 44mm catalog#: 115370 lot#: 571090, comp primary stem 15mm mini catalog#: 113635 lot#: 74306, comp rvsr shldr glnsp +3 36mm catalog#: 115313 lot#: 913190, comp lk scr 3.5hex 4.75x25 st catalog#: 180552 lot#: 641720, comp lk scr 3.5hex 4.75x30 st catalog#: 180553 lot#: 876310, comp lk scr 3.5hex 4.75x15 st catalog#: 180550 lot#: 494330, comp rvs cntrl 6.5x25mm st/rst catalog#: 115395 lot#: 566410, arcom xl 44-36 std hmrl brng catalog#: xl-115363 lot#: 927310.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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

It was reported that during a total shoulder arthroplasty, the surgeon was unable to assemble the humeral bearing into the humeral tray.A new tray and bearing were utilized to complete the procedure.There were no patient consequences as a result of the malfunction.

• Brand Name: ARCOM XL 44-36 STD HMRL BRNG
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6849175
• MDR Text Key: 86103727
• Report Number: 0001825034-2017-06990
• 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
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2022
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 927520
• Other Device ID Number: (01)00880804478427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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 Age: 68 YR