MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE GLENOSPHERE; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Reaction (2414)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown which glenosphere was implanted in the patient.It is one of the following product id's: part#: 00434904011, 40mm tm reverse glenosphere, lot# unk or part#: 00434903611, 36mm tm reverse glenosphere, lot# unk.Concomitant medical products: part number 00-4349-036-11, glenosphere 36 mm diameter, has also been listed as a possible device explanted during the revision.It has not been made clear which glenosphere was explanted from the patient at this time.Attempts to obtain further information are currently in process.01.04223-018, reverse screw, lot # unk, 01.4223-048, reverse screw, lot # unk, 01.04207.072, humeral stem, lot # unk, 01.4207.142, humeral stem, lot # unk, 01.04223.100, humeral shell, lot # unk, 01.04223.106, humeral shell, lot # unk, 01.4223.360, lot # unk, 01.04223.400, lot # unk.Event occurred in (b)(6).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.

Event Description

It was reported that a patient underwent a reverse shoulder arthroplasty revision due to infection after an unknown duration following the primary procedure.All components were removed.Competitor product was re-implanted.Attempts are being made, and no further information as been provided at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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 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.

Event Description

Further information provided from the complainant alleges that the patient also experienced metallosis due to notching.Attempts have been made and no further information is available.

• Brand Name: TM REVERSE GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 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: 8071697
• MDR Text Key: 127201539
• Report Number: 0001822565-2018-06422
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121543
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention