MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MULTIPOLAR LINER 28 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Foreign Body Reaction (1868); Hair Loss (1877); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see report(s): 0002648920 - 2018 - 00054, 0001822565 - 2018 - 00519.Additional concomitant medical products: 00801802802, femoral head, lot 60224808; 00500104800, shell 48 mm o.D., lot 75712700; 00783401300, versys ld/fx pressfit, lot 60213009.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported a patient is experiencing extreme pain, itching, swelling, hot to the touch, instability, metal poisoning and hip "feels like sandpaper" approximately 13 years post-implantation of left total hip arthroplasty.It is also noted that the patient is experiencing an open wound infection on left leg that occurred greater than one year post op.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

The reported udi is wrong.Udi is not availabe for this item as it was manufactured before they were printed on the label.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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.

• Brand Name: MULTIPOLAR LINER 28 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7218981
• MDR Text Key: 98226351
• Report Number: 0001822565-2018-00523
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2006
• Device Model Number: N/A
• Device Catalogue Number: 00500104728
• Device Lot Number: 75246500
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 79