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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Reaction (2414)

Event Date 04/01/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has not 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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2018-07987, 0001825034-2018-07988, 0001825034-2018-07990.

Event Description

It was reported a patient underwent initial total hip arthroplasty.Patient presented with complaints of persistent erythema and drainage.The wound was locally debrided and steri-strips were applied.On the next visit the wound increased in size and drainage.Subsequently, patient underwent wound revision due to wound dehiscence and suture reaction.

Manufacturer Narrative

(b)(4).The follow-up report is being submitted to relay additional information.Reported event was confirmed from medical records received.No product was returned; visual and dimensional evaluations could not be performed.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Review of operative notes confirmed that the patient underwent wound revision.Patient came to office and had continued drainage and redness to wound.The wound had dehisced and previous local incisional debridement was performed and steri strips had been applied, along with implementing oral keflex.Surgeon also reports that patient had infection of staph previously (unknown date) in foot and ankle.During the revision the wound had been prepped, dissection went only to the subcutaneous area and no further tracking was identified.A definitive root cause cannot be determined with the information 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: UNKNOWN TAPELOC STEM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7769689
• MDR Text Key: 116647773
• Report Number: 0001825034-2018-07991
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• 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
• Date Manufacturer Received: 08/21/2018
• 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
• Patient Age: 64 YR
• Patient Weight: 100