MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Photographs were received and will be reviewed as part of ongoing investigation.The device history records were reviewed and found to be conforming.An e-mail requesting additional information was sent on (b)(6) 2018 to the appropriate representatives.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

It was reported that black scratches were found on a biolox delta, ceramic femoral head, m, 36/0, taper 12/14.The device has not been implanted and the surgery was completed with another device with one hour delay.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: scratches on surface.Review of event description: primarily, it was reported that during a surgery a biolox head was found with scratches on the surface.The surgery was delayed for more than 1 hour.During complaint intake it was recognized, according to the received pictures of the concerned device and packaging, that lot number engraved on the head does not correspond with packaging label.Accordingly, it was detected by zimmer biomet china that with the china distributor a mix-up of the device must have occurred.The responsible sales rep.Is no longer with the company; therefore it is not possible to gain more information on this specific matter.However, at distributor side corrective actions were to prevent such event in future were implemented in the process as follows: 1.Optimize new warehouse management system and procedures.2.Strictly control the quality and quantity of received goods.3.Check out the stock to make sure there are no tools/implants left after each operation.4.Updated the software to control the storage, outbound, migration, disposal.5.Establish the product traceability system.6.Training to employee of job description and responsibility.Based on the above it is concluded that the mix-up did happen outside of the manufacturing cycle, but somewhere at the distributor's site.The product in question was manufactured and packaged according specification.In addition the complainant withdrew the complaint after the mix-up issue has been discovered.Nevertheless, the case was investigated as usual to evaluate the reported scratches, regardless the detected circumstance described above, with outcome as follows: review of received data: pictures were received, showing the head and the packaging.Metallic transfer on the surface of the head can be seen.Device analysis: no product was returned to zimmer biomet for in-depth analysis.According to the available information, the product location is unknown.Review of product documentation: no product documentation was reviewed for investigation.Root cause analysis: root cause determination using rmw: - increased wear, damaged implant due to inadequate handling of the medical device in the or leading to damaged device => possible, correct handling of the device during the operation is not under zimmer biomet control.Conclusion: the product was not received for investigation, however pictures of the device were received.The review of the dhr indicates that the head met all requirements to perform as intended.Moreover, the surface of the head is 100% visually inspected before it is released.Most probably the scratches on the surface of the head occured during handling of the device outside of zimmer biomet control.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).

Event Description

No event update.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7497638
• MDR Text Key: 107689092
• Report Number: 0009613350-2018-00504
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 2927618
• Other Device ID Number: 00889024430365
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/29/2018
• 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