MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. TESS HUM STEM SMALL; SHOULDER PROSTHESIS

Catalog Number P1700128

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: tess glenoid cemented pe s3; item# p1700426; lot# unknown.Tess hum centred head 52mm; item# p1700140; lot# unknown.Tess hum anatomical corolla s3; item# p1700446; lot# unknown.G2 - foreign: france.Multiple mdr reports were filed for this event, please see associated reports: 3006946279-2023-00106.3006946279-2023-00107.3006946279-2023-00108.The products remain implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified the evacuation of hematoma approximately seven years and six months ago.Implants remain implanted.No other information has been found.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient developed a hematoma post implantation.A reoperation was subsequently performed two days post implantation to evacuate the hematoma.No implants were explanted.No further event information available at the time of this report.

• Brand Name: TESS HUM STEM SMALL
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18317881
• MDR Text Key: 330375129
• Report Number: 3006946279-2023-00109
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03599870074350
• UDI-Public: (01)03599870074350
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: P1700128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 106 KG