MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL BODY POROUS CEMENTLESS 12/14 TAPER 40 MM NECK OFFSET; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult or Delayed Positioning (1157); Difficult to Insert (1316)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical products: item number: 14-107017, item name: freedom constrained modular head, lot #: 149540, item number: 14-107018, item name: freedom constrained modular head, lot #: 916870, item number: unknown, item name: unknown ringloc cup, lot #: unknown, item number: unknown, item name: unknown ringloc liner, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the femoral head would not seat onto the stem.Another head was attempted and did not seat.At this point all implants except for the cup were removed and replaced.Attempts have been made and no additional information is available.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.The reported zimmer femoral stem was used in conjunction with a biomet freedom constrained modular head and liner system.These components are not compatible, as indicated in the instructions for use for the freedom constrained liner system.It was identified that the reported zimmer femoral stem was used in conjunction with a biomet freedom constrained modular head and liner system.These products are incompatible.Therefore, the root cause of this event can be attributed to off-label use of the devices.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

It was reported that the femoral head would not seat onto the stem.Another head was attempted and did not seat.At this point all implants except for the cup were removed and replaced.There was approximately a one hour delay to the procedure.Attempts have been made and no additional information is available.

• Brand Name: FEMORAL BODY POROUS CEMENTLESS 12/14 TAPER 40 MM NECK OFFSET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8110265
• MDR Text Key: 128579297
• Report Number: 0001822565-2018-06594
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K113296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• 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: 00999601945
• Device Lot Number: 63021124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2019
• 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