MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR HUMERAL HEAD 21 MM HEAD HEIGHT 46 MM SPHERICAL HEAD DIAMETER; PROSTHESIS, EXTREMITIES

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 00430000913; modular humeral stem 9 mm stem diameter 130 mm; lot# 61467261, item# 00430204046; glenoid component pegged 46 mm diameter; lot# 60801282 unk medullary plug, palacos r+g cement; lot# 71485218.Report source: (b)(6).The product will not be returned 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: 0001822565-2019-04599, 0001822565-2019-04603, 0001822565-2019-04604.Remains implanted.

Event Description

It was reported approximately eight years post-implantation, patient continues to experience pain, severe deltoid atrophy, subluxation with inferior dislocation of the humeral head, and brachial plexus injury.She uses a sling intermittently.Patient informed she may have long-term atrophy and weakness of the proximal muscles due to brachial plexus injury.Attempts to obtain additional information have been made; however, no more is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.Reported event was confirmed by review of medical records which stated the following: -severe atrophy of the deltoid muscle, weakness of internal and external rotation -x-ray showed that she had a total shoulder arthroplasty with subluxation of the humeral component probably related to the severe deltoid dysfunction and possible cuff dysfunction.-x-ray report: subluxation / inferior dislocation of the humeral head prosthesis relative to the glenoid prosthesis.Emg report: -patient reports very minimal improvement in function of the shoulder, marked atrophy over the deltoid muscles, and persistent numbness over the left lateral shoulder and paresthesias in the left medial forearm and into the fourth and fifth digit of the left hand.-there is evidence of a left brachial plexus injury which is patchy, but primarily involving the upper trunk and posterior cord muscles deltoid muscle severely impaired and is quite fibrotic on emg which indicates that the majority of nervous innervation to that muscle is not intact.-i suspect this woman will have long-term atrophy and weakness of the proximal muscles due to this brachial plexus injury hyperreflexia of the left arm which could be suggestive of a superimposed cervical stenosis at c5-c6.This could be contributing somewhat to her symptomatology.Surgeon correspondence: -letter from primary surgeon (belgium) to canadian surgeon regarding the primary surgery.Suggestion that pain may have been caused by progressive degeneration of the nerve and/or trauma during forced mobility.The belgian surgeon mentioned seeing the patient in 2015 during which he noted a lowering of the humeral head signaling atrophy of the deltoid muscle and a weak axillary nerve as well as a weak inferior gleno-humeral ligament.This was not present during her previous consultation.-the prosthesis provided by zimmer for a replacement of the bigliani-flatow prosthesis did not correspond to the initial plan as it is meant for traumatic cases.The difference between the top of the greater tubercule and the top of the prosthetic spherical head did not match a normal anatomy.I looked for answers, at the time, but only obtained diverging views.I concluded that the implant were established as reconstruction material to treat fracture instead of arthritis.Device history record was reviewed and no discrepancies were found.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.Zimmerbiomet will continue to monitor for trends.

• Brand Name: MODULAR HUMERAL HEAD 21 MM HEAD HEIGHT 46 MM SPHERICAL HEAD DIAMETER
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9238226
• MDR Text Key: 163794786
• Report Number: 0001822565-2019-04601
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K982981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00430004621
• Device Lot Number: 61572051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86