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); Compatibility Problem (2960); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Effects, number 9 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions.¿ number 13 states, ¿intraoperative or postoperative bone fracture and/or postoperative pain.¿ this report is number 2 of 4 mdrs filed for the same patient (reference 0001825034-2016-02804 / 0001825034-2016-02807).Product location unknown.

Event Description

Patient underwent a shoulder revision procedure approximately 19 months post implantation due to dislocation and pain.The glenosphere was 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.

Manufacturer Narrative

This follow-up report is being filed to relay additional and corrected information, which was unknown at the time of the initial medwatch.(b)(4).

Event Description

Patient underwent a shoulder revision procedure approximately 19 months post implantation due to dislocation and pain.The glenosphere was removed and replaced.Op report states that there was fluid found in the joint and wear was noted on the inferior lip of the humeral bearing.The glenosphere was identified as being displaced for the joint and loose.Metallosis was noted in the joint capsule.Both the glenosphere and humeral bearing were removed and replaced.

Manufacturer Narrative

This report is being amended to reflect corrections and additional information.Product or photos were not returned, therefore condition of device is unknown and examination could not be performed.This device is used for treatment.Complaint history review identified no other complaint on this part and lot combination.Per surgical technique, the implants are compatible with one another.The revision op notes noted significant wear which may have led to the dislocation.Root cause remains undetermined without product return.

• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5831455
• MDR Text Key: 50713612
• Report Number: 0001825034-2016-02805
• 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: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: XL-115363
• Device Lot Number: 450680
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2013
• 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