MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. TESS GLEN INSERT S2; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Rupture (2208); Joint Dislocation (2374)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi # (b)(4).Concomitant medical products: p1700332 tess glenoid cmtless bseplt s2, lot # 0001141097.P1700004 tess glen hum screw 4.5x30, lot#0001174143.P1700004 tess glen hum screw 4.5x30, lot#0001164126.P1700136 tess hum centred head 48mm, lot# 0001069725.P1700446 tess hum anatomical corolla s3, lot#0001142834.P1700128 tess hum stem small, lot#0001160372 report source- foreign.The event occurred in (b)(6).This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k060694.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was revised to address dislocation of the right glenoid shoulder component.It was identified the subscapularis tendon ruptured with low retraction.The liner and the upper screw was removed.Only the liner was replaced.No further information has been made available at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: TESS GLEN INSERT S2
• 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: 7048354
• MDR Text Key: 92613049
• Report Number: 3006946279-2017-00259
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/07/2018
• Device Model Number: N/A
• Device Catalogue Number: P1700485
• Device Lot Number: 0000813784
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2013
• 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: 59 YR