MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Disassembly (1168); Fracture (1260); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/10/2015

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 14 states, "scapular notching and bone erosion has been reported with the use of reverse shoulder implants.Scapular notching may lead to early failure of glenoid fixation." "intraoperative and early postoperative complications can include.Temporary or permanent nerve damage resulting in pain or numbness to the affected limb." this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-04455 / 04456 / 04458).

Event Description

It was reported by the patient to the legal department that the patient had an initial right total shoulder arthroplasty on (b)(6) 2014.Subsequently, the patient had a right manipulation on (b)(6) 2015 and a revision to a reverse shoulder on (b)(6) 2015 due to minimal mobility.On (b)(6) 2015, the patient had a revision due to allegations of a snapping sound, pain, limp arm, fractured taper adapter, and disassociation of the glenosphere.During the revision it was noted by the surgeon that two screws had damaged the bone and there was damage to the implant and bearing.This report is based on allegations set forth in the patient's claim, there is no legal representation at the time of receipt of complaint.

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 information, which was unknown at the time of the initial medwatch.

Event Description

It was reported by the patient to the legal department that the patient had an initial right total shoulder arthroplasty on (b)(6) 2014.Subsequently, the patient had a right manipulation on (b)(6) 2015 and a revision to a reverse shoulder on june 22, 2015 due to minimal mobility.On (b)(6) 2015, the patient had a revision due to allegations of a snapping sound, pain, limp arm, fractured taper adapter, and disassociation of the glenosphere.During the revision it was noted by the surgeon that two screws had damaged the bone and there was damage to the implant and bearing.This report is based on allegations set forth in the patient's claim, there is no legal representation at the time of receipt of complaint.Additional information received from the patient reported they are unable to lift their right arm above their head or to extend their right arm out to their side without help.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.During the evaluation, the bearing and baseplate showed evidence of excessive wear while the other components showed evidence of normal wear.Also the taper adapter showed no evidence of fracture.A conclusive root cause could not be determined.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 12 states, "wear and/or deformation of articulating surfaces." this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-04455 / 04456 / 04458).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Upon receipt of mw5062575 on june 28, 2016, it was discovered medical records had been previously received by zimmer biomet on february 3, 2016.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported by the patient to the legal department that the patient had an initial right total shoulder arthroplasty.Subsequently, the patient had a right manipulation approximately 6 months post-implantation and a revision to a reverse shoulder approximately one year post-implantation due to minimal mobility.The patient underwent a second revision approximately one year post-implantation due to allegations of a snapping sound, pain, limp arm, fractured taper adapter, and disassociation of the glenosphere.During the revision it was noted by the surgeon that two screws had damaged the bone and there was damage to the implant and bearing.This report is based on allegations set forth in the patient's claim, there is no legal representation at the time of receipt of complaint.Operative reports indicated the first revision was performed approximately one year post-implantation due to the patient's rotator cuff dysfunction and pain.It was also noted that the patient had tightness present.The hemi-arthroplasty was revised to a reverse shoulder.The second revision op report (approximately one year post-implantation) noted that the glenosphere was loose in the joint space.The baseplate was then examined and found to be damaged on the inferior aspect.Additionally, the inferior screw was loose.All components were removed and invoices shows that the patient was converted to a hemi-arthroplasty.The bone voids were grafted with competitor cortical cancellous bone.A humeral head and a taper adaptor were implanted.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Upon receipt of additional information, no device failure was mentioned.The glenosphere did not dissociate from the taper; however, the taper dissociated from the baseplate.The glenosphere did not cause or contribute to the reported event.

• Brand Name: COMP RVRS SHLDR GLNSP STD 36MM
• 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: 5189285
• MDR Text Key: 29924074
• Report Number: 0001825034-2015-04455
• 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,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 163220
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2015
• 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: 68 YR
• Patient Weight: 100