MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-36; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).Note: the following case is associated with this case: (b)(4).

Event Description

It was reported that the patient underwent a revision surgery due to infection.Additional information has been requested.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Correction: b4, g4, g7, h10.Additional: h2, h6.Event summary: it was reported that the patient underwent a total shoulder arthroplasty on an unknown date.Subsequently, the patient has been revised due to infection on the (b)(6) 2019.A spacer was implanted.Review of received data: no medical data such as surgical notes, lab tests or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Conclusion summary it was reported that the patient underwent a total shoulder arthroplasty on an unknown date.Subsequently, the patient has been revised due to infection on the (b)(6) 2019.A spacer was implanted.The investigation results did not identify a non-conformance or a complaint out of box (coob).As no lab results or surgical reports have been received, the nature of the infection cannot be assessed.The lot number remains unknown, therefore the irradiation certificate of the affected lot could not be reviewed.However, no trend on infection has been observed for this item number.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that a disadvantageous product design favoured or contributed to the infection.Nevertheless, an infection can have numerous root causes.Possible causes of infection could include wrong handling of device due to wrong information, packaging failure during transportation as well as surgical and patient related factors.Based on the available information, we were not able to identify an exact root cause for the infection.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-36
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9154947
• MDR Text Key: 161581332
• Report Number: 0009613350-2019-00588
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024483040
• UDI-Public: 00889024483040
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention