MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/H RADIAL SOLID/APX SHL 50MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Thrombosis (2100)

Event Date 04/28/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 51-107170, stem, lot # unk, item # 11-363661 , head, lot # unk, item # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05602, 0001825034 - 2018 - 05604, 0001825034 - 2018 - 05605.

Event Description

It was reported that approximately 6 months post implantation, the patient was noted to have developed a dvt, and cellulitis to the foot, leg, hip, back, and neck.Attempts have been made and no further information has been provided.

Manufacturer Narrative

The following report is being updated based on the additional information received.Concomitant medical products : 51-104110 tprlc 133 t1 pps ho 11x142mm, 650-1056 cer bioloxd option hd 32mm, 650-1065 cer option type 1 tpr sleve -3, unknown e1 liner.The complaint cannot be confirmed since operative notes or x-rays were not provided from the event.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-05602, 0001825034-2018-05604, 0001825034-2018-05605, 0001825034-2018-08930.

• Brand Name: M/H RADIAL SOLID/APX SHL 50MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7768031
• MDR Text Key: 116594137
• Report Number: 0001825034-2018-05603
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK861114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 13-104050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 79