MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN SHOULDER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "shoulder arthroplasty for osteoarthritis secondary to glenoid dysplasia: an update" which explores the role of anatomic shoulder arthroplasty (both hemiarthroplasty and total shoulder arthroplasty) in treatment of glenoid dyplasia with osteoarthritis.The study was conducted between 1980 and 2008.Twenty (20) patients underwent anatomic shoulder arthroplasty (22 shoulders) for treatment of osteoarthritis secondary to glenoid dysplasia.There were eight (8) hemiarthroplasties and fourteen (14) total shoulder arthroplasties.The average follow-up was 6 years.It was reported by the surgeon that the majority of the patients received competitor components.A patient was identified in the journal article that experienced postoperative pain.There was no revision procedure reported.There has been no further information provided and the patient outcome is unknown.The above referenced journal article is attached to this medwatch and the manufacturer report number of the medwatch which reports on all patients (identified and non-identified) mentioned in the journal article is 1825034-2015-00137.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not fully provided for this patient mentioned in the journal article.Initial reporter -the article was written by benjamin allen, md, bradley schoch, md, john w.Sperling, md, mba, robert h.Cofield, md; j shoulder elbow surg (2014) 23, 214-220; journal of shoulder and elbow surgery board of trustees.Http://dx.Doi.Org/10.1016/j.Jse.2013.05.012 it is likely that the complication for this patient has already been reported; however, it cannot be determined based on the limited patient information made available in the article.Should additional information relating to the patient complication be received, the updated information will be forwarded to the fda.

Manufacturer Narrative

Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.(b)(4).This report is being submitted late as it has been identified in remediation.

Event Description

This article identified one (1) patient who experienced pain and glenoid arthrosis at 20 months postop¿.It was noted that one of the patients who was revised for pain developed severe posterior subluxation and two metal backed neer ii components were surrounded by a 105mm complete lucent line with a shift in component position in one; however, no other information is available for specific identity.

• Brand Name: UNKNOWN SHOULDER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 4409514
• MDR Text Key: 18541881
• Report Number: 0001825034-2015-00103
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 51 YR