MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 44 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer liner cat#00500104428, lot#64302970.Zimmer stem cat#00771101010, lot#64172709.Zimmer head cat#00877502802, lot#2992432.Foreign report source: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00159.0001822565 - 2020 - 00828.

Event Description

It was reported the patient developed fever and wound exudation approximately 1 week after initial tha and was given anti-infection treatment, wound debridement and dressing change.Approximately 3 weeks later, patient underwent debridement surgery.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed with medical records provided.Review of the available records identified the following: after revision, the patient developed pulmonary infection and underwent a wound debriment procedure.Yellow exudate was observed.Peroxide and antibiotics were applied to the wound.No other complications / significant findings related to the reported event were noted.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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: SHELL 44 MM O.D.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9819551
• MDR Text Key: 191128810
• Report Number: 0002648920-2020-00160
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00500104400
• Device Lot Number: 64316784
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other