MAUDE Adverse Event Report: ZIMMER GMBH BIOLOXA OPTION, HEAD, XL, 32/+7, TAPER 12/14; BIOLOX OPTION, HEAD, XL, ø 32/+7, TAPER 12/14

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to infection.

Event Description

Please refer to report 0009613350-2019-00440.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: correction: b4 - g4 - g7 - h10.Trend analysis: no trend has been identified.Event description: it was reported that the patient was implanted with biolox option head on (b)(6) 2016 and revised on (b)(6) 2016 due to infection.Review of received data: approximately 10 days postop developed a clear drainage with no systemic sign.Labs, clinical course and direct observation clearly demonstrate an acute postoperative infection.Intraoperative cultures from 2 weeks ago were negative.Purulent drainage that communicated within the joint space and necrotic tissue noted.A lacquer like layer of debris was removed from inside the acetabulum.Acetabulum noted to be well ingrown, acetabular screw replaced.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the device is intended for treatment.The compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed on: 06-mar-2020.The review showed that the materials were manufactured according to specification.Sterilization certificate reviewed on: 06-mar-2020.The review showed that the devices were sterilized according to specification.Conclusion: it was reported that the patient was implanted with biolox option head on (b)(6) 2016 and revised on (b)(6) 2016 due to infection.In vivo time of the device is 18 days.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the available information, we were not able to identify an exact root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOXA OPTION, HEAD, XL, 32/+7, TAPER 12/14
• Type of Device: BIOLOX OPTION, HEAD, XL, ø 32/+7, TAPER 12/14
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8774821
• MDR Text Key: 150524013
• Report Number: 0009613350-2019-00440
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430501
• UDI-Public: 00889024430501
• Combination Product (y/n): N
• PMA/PMN Number: K073567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-032-04
• Device Lot Number: 2616158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2020
• 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