MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI-ANGULAR HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); No Information (3190)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned [as it remains implanted at this time] 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 the patient has been indicated for a shoulder revision due to instability.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical product - mosaic mod prox hmrl seg 80 mm, cat#: 111003 lot#: 329950; mosaic +10 mm proximal body, cat#: 111001 lot#: 303000; cps transverse pin 6pk 20 mm, cat#: 178524 lot#: 332470; female cps/male mosaic tpr, cat#: cp560752 lot#: 904870; cps nut co-cr-mo alloy, cat#: 178512 lot#: 837120; cps xs sht spdl w pins 600lbf, cat#: 178363 lot#: 410410; diah seg lock screw set (2 qty), cat#: 150481 lot#: 0000143488; cps short anchor plug 10 mm, cat#: 178552 lot#: 675350; cps taper locking cap / oss sc, cat#: 178710 lot#: 553290.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 the patient underwent a right shoulder revision from a proximal humerus hemi-arthroplasty due to instability caused by rotator cuff issues approximately five (5) years post-implantation.The patient was converted to a reverse shoulder.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.The reported event is confirmed.Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found.No device or photos were received; therefore the visual inspection was not performed.Per surgical technique, the devices on this complaint are compatible with one another.Review of the complaint history determined that no further action is required.X-ray review was conducted.The root cause was determined to be patient soft tissue condition.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: BI-ANGULAR HUMERAL HEAD
• 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: 6429335
• MDR Text Key: 70702938
• Report Number: 0001825034-2017-01853
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PK032895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2017

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: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 114052
• Device Lot Number: 893240
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: 06/30/2017; 09/22/2017
• Supplement Dates FDA Received: 07/26/2017; 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2008
• 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: 25 YR
• Patient Weight: 65