MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM REVERSE 40MM GLENOSPHERE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930); Pain (1994); Pneumonia (2011)

Event Date 01/01/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Onset on an unknown date in early (b)(6) 2017.Concomitant devices ¿ tm reverse 40mm glenosphere catalog#: 00-4349-040-11 lot#: 61940709, stem catalog#: 00-4349-014-13 lot# 62185909, spacer catalog#: 00-4349-039-12 lot#: 62112778, liner catalog#: 00-4349-066-06 lot#: 61039693.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.This report is number 2 of 5 mdrs filed for the same patient (reference 0001822565-2017-04467, 0001822565-2017-04468, 0001822565-2017-04469, 0001822565-2017-04474).

Event Description

It was reported that a patient experienced pain and aching, from the operative shoulder to the elbow, and infection approximately four (4) years post-operatively of a reverse total shoulder arthroplasty.The patient reportedly had some degree of pain ever since the primary surgery, however had worsened along with the appearance of boils, which was determined to be an infection under the patient's arm four (4) years post-operatively.The patient was prescribed antibiotics.Approximately three to four (3-4) months after onset, the patient was admitted to the hospital due to the infection that had spread to the lungs, along with the onset of pneumonia.Subsequently, the patient expired.The operative shoulder/arm was reportedly non-functional and non-responsive at the time of passing.There is no objective evidence to substantiate the product/implant caused or contributed to the patient's death at this time.Attempts have been made to obtain additional information however further information is not 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.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: ZIMMER TM REVERSE 40MM GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6688203
• MDR Text Key: 79115922
• Report Number: 0001822565-2017-04578
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00434904011
• Device Lot Number: 61940709
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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): Death; Hospitalization
• Patient Age: 70 YR
• Patient Weight: 75