MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN BIPOLAR HIP INSERT; N/A

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The following reports are associated with this event: 0009613350-2020-00174.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 a patient underwent revision surgery due to dislocation.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This device (ref: 61.27.28-42.Lot: 3012076) or similar device is not approved in us.Therefore this report can be deleted from the system.

Event Description

This device (ref: 61.27.28-42 lot: 3012076) or similar device is not approved in us.

• Brand Name: UNKNOWN BIPOLAR HIP INSERT
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9933245
• MDR Text Key: 194006980
• Report Number: 0009613350-2020-00173
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Report Date: 05/27/2020

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?: 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
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN AVENIR STEM.; UNKNOWN BIOLOX HEAD HIP.
• Patient Outcome(s): Hospitalization; Required Intervention