MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18; N/A

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

The actual device reported is not marketed in usa, but devices with similar characteristics (k053274) are marketed in usa, and therefore this report was filed.As no lot number was provided, the device history records could not be reviewed.Concomitant medical products and therapy date: detail of product: item # unknown, item name: anatomical shoulder fracture, humeral stem, 7- 130, lot # unknown.Item # unknown, item name: anatomical shoulder reverse, humeral cup, 0°, retro, lot # unknown.Item # unknown, item name: anatomical shoulder reverse, humeral insert, pe, 36-0, lot # unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Additional information has been requested and is currently not available.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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that patient underwent revision surgery due to infection.

Manufacturer Narrative

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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was additionally reported that the patient was revised due to infection and metallosis due to notching.

Event Description

Please refer to report 0009613350-2018-01160.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the dhr check could not be performed as the lot number was not available.Trend analysis: no trend considering the following event is identified: infection or metallosis through notching.Event description: it was reported that the patient underwent a reverse total shoulder arthroplasty on a unknown date.Subsequently, the devices were explanted on (b)(6) 2018 due to infection and metallosis through notching.The stage 2 surgery was performed on an unknown date and devices of another company have been re-implanted.This is a split case with warsaw, glenoid baseplate and glenoid sphere head are covered in (b)(4).Review of received data: no medical data such as surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the combination of these product types were approved by zimmer biomet.However, the exact sizes of the devices are unknown, the full compatibility cannot be confirmed.Conclusion: it was reported the implants were explanted due to metalosis through notching and infection.Neither operative notes, office visit notes, nor explanted implants were received.Patient factors that may affect the performance of the components such as bone quality and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Therefore, the complaint could not be confirmed.The issue of metallosis through notching could be related to impingement between the devices or between the surrounded tissue and devices as well as fretting between components.However, due to the significant lack of information, an accurate analysis is not possible.The device history records, sterilization certificate and the product expiration date could not be reviewed due to the lack of precise reference number and lot number.However, no trend on infection has been observed for these product families.It is highly unlikely that a disadvantageous product design favored or contributed to the event.Further, the ifu states that wound infection are one of the possible adverse effect and should be considered when implanting zimmer biomet devices.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).

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-18
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8094749
• MDR Text Key: 128048859
• Report Number: 0009613350-2018-01160
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention