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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378); Reaction (2414)

Event Date 06/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record 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.Unique identifier (udi) #: n/a.Concomitant medical products: item # unk, stem, lot # unk; item # unk, head, lot # unk; item # unk, shell, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04971, 0001825034 - 2018 - 04972, 0001825034 - 2018 - 04973.

Event Description

It was reported that approximately 6 weeks post implantation, the patient had presented with dehiscence to the distal portion of the wound, about 1 cm long, and serous fluid.Subsequently, patient was revised due to concern that they were having a suture reaction.Revision was due to non-healing wound, due to suture reaction, no implants were explanted or implanted during this procedure.Attempts were made and no further information has been provided.

Manufacturer Narrative

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

• Brand Name: BIOMET UNKNOWN LINER
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7754524
• MDR Text Key: 116217473
• Report Number: 0001825034-2018-04975
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• 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: 10/02/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 125