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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Scratched Material (3020)

Patient Problems Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-04949 / 04919).

Event Description

It was reported that during a reverse shoulder procedure, upon opening the implant package, the trunnion of the baseplate was noticed to be covered in scratches.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Concomitant medical product: comp fx hum pos sleeve 16mm, cat#: 113584 lot#: 094320; comp nlk scr 3.5hex 4.75x30 st, cat#: 180560 lot#: 140060; compr 14mm hum fract stem pps, cat#: 12-113564 lot#: 115510; comp fx hum pos sleeve 17mm, cat#: 113585 lot#: 804120; comp rvs cntrl 6.5x25mm st/rst, cat#: 115395 lot#: 456790; comp lk scr 3.5hex 4.75x35 st, cat#: 180554 lot#: 895030; comp lk scr 3.5hex 4.75x30 st, cat#: 180553 lot#: 425730; comp lk scr 3.5hex 4.75x30 st, cat#: 180553 lot#: 704610; comp lk scr 3.5hex 4.75x25 st, cat#: 180552 lot#: 871390; comp.Rev shldr 9 in steinmann, cat#: 405800 lot#: 562530; comp rvs tray +5mm co 44mm, cat#: 115375 lot#: 955200; comp rvrs 25mm bsplt ha+adptr, cat#: 010000589 lot#: 342420.Customer has indicated that the product will not be returned [location unknown] 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: 0001825034-2016-04919 and 0001825034-2017-01976.

Event Description

It was reported that a patient underwent a shoulder revision due to dislocation approximately 1 year post-implantation.All components were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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 as no were trends identified.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.

• 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: 6137123
• MDR Text Key: 61199432
• Report Number: 0001825034-2016-04919
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2017

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: 03/04/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 127820
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/23/2017; 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR