MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER NEUTRAL 28 MM I.D. SIZE FF FOR USE WITH 46 MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Peeled/Delaminated (1454); Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Source: (b)(6).Concomitant medical products: catalog number:00875304601, lot number:64326501, brand name: trilogy shell.Catalog number:163660, lot number: j6303568, brand name: cocr head.Catalog number: 21-103202, lot number: 6252580, brand name: taperloc femoral stem.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01929.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.H3 other text : device not returned for evaluation.

Event Description

It was reported that a patient had an initial hip surgery.Approximately 2 weeks post implantation, the patient began experiencing drainage from the wound.An irrigation and debridement procedure was performed.A few days later, the patient dislocated the hip and was revised.The assumption of a deep infection was reported.The liner was revised, which was visibly delaminating.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

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 was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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.

Manufacturer Narrative

The investigation was reopened as the reported liner was returned for evaluation.As returned, damage in the form of thru holes is seen that runs across the diameter of the device and from inner surface to backside surface.This damage appears to have occurred during removal.The device does not show signs of delamination.Additional information provided does not change the root cause of the previous investigation.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: LINER NEUTRAL 28 MM I.D. SIZE FF FOR USE WITH 46 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10106741
• MDR Text Key: 195130375
• Report Number: 0001822565-2020-01928
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024149069
• UDI-Public: (01)00889024149069(17)231130(10)64165957
• Combination Product (y/n): N
• PMA/PMN Number: K151448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00875100728
• Device Lot Number: 64165957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 60