MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. HUM ANATOMICAL COROLLA S0; PROSTHESIS, SHOULDER

Catalog Number P1700440

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

Patient Problems Fall (1848); Muscle/Tendon Damage (4532)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2-foreign- france d10.Item#:p1700484 ;lot#:unknown ;item name: tess glen insert s1 ; item#:p1700440 ;lot#:unknown ;item name: tess hum centered head 43 ; item#:p1700331 ;lot#:unknown ;item name: tess glenoid cmtless bseplt s1; item#:p1700128 ;lot#:unknown ;item name: tess hum stem small ; multiple mdr reports were filed for this event, please see associated reports: 3006946279 - 2023 - 00121 3006946279 - 2023 - 00095 investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent revision surgery due to cuff lesion.Due diligence performed, all the received information was captured.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; 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 avascular necrosis as contributing factor of the event.Moreover, patient fall on shoulder spring 2019, which led to the prosthesis replacement for mechanical reasons.The root cause of the reported issue is attributed to a patient accident (fall on his shoulder).As per instructions for use, falls are listed as factors which may compromise successful implantation and device performance.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.H3 other text : device location is unknown.

Event Description

Initial right anatomic shoulder arthroplasty performed.Subsequently, the patient was revised due to cuff lesion four (4) years six (6) months after initial surgery.No further details or outcomes have been provided.

• Brand Name: HUM ANATOMICAL COROLLA S0
• Type of Device: PROSTHESIS, SHOULDER
• 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: 18353797
• MDR Text Key: 330863641
• Report Number: 3006946279-2023-00122
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03599870103531
• UDI-Public: (01)03599870103531
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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: Lay User/Patient
• Device Catalogue Number: P1700440
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/05/2024
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 46 KG