MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Reaction (2414)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown head ,lot #: unknown; item #: unknown, unknown liner, lot #: unknown; item #: unknown, unknown cup, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03867, liner.0001822565-2019-03868, head.

Event Description

It was reported by the legal group patient underwent an initial left tha and subsequently was revised nine years later for metallosis, dislocation, pain, implant corrosion, elevated ions, soft tissue damage from impingement, instability, and limited mobility.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).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

No further event information available at the time of this report.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8977110
• MDR Text Key: 156976812
• Report Number: 0001822565-2019-03870
• Device Sequence Number: 1
• Product Code: LZO
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2019
• 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