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

Model Number N/A

Device Problems Material Erosion (1214); Noise, Audible (3273)

Patient Problem Muscle Weakness (1967)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown liner, pn unknown, ln unknown.Unknown cup, pn unknown, ln unknown.Unknown stem, pn unknown, ln unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00993, 0001822565-2019-00995, 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.

Event Description

It was reported that patient is experiencing grinding noise, metal shards in blood and weak muscles causing the joint to slip approximately 9 years post-implantation.A revision procedure has been indicated; however, it has not been reported at this time.Attempts were made to obtain additional information; however, none was available.

Event Description

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

Manufacturer Narrative

Upon receipt of additional information, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: UNKNOWN HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8392435
• MDR Text Key: 137928564
• Report Number: 0001822565-2019-00992
• 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
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 51 YR
• Patient Weight: 117