MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA HD 12/14 40X-3.5; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Failure to Disconnect (2541)

Patient Problem Failure of Implant (1924)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date detail of product: item # 0106010003, item name avenir, stem, standard, uncemented, ha, 3, taper 12/14, lot # 2942684.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.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

It was reported that during revision surgery surgeon couldn't manage to remove the ceramic head on the stem.He had to remove the stem as well to remove the head.

Manufacturer Narrative

Dhr review: ref#: 01.06010.003 lot#: 2942684 - yield: 39 - delivered: 38 - scrapped: 1 parts scrapped due to the plate to machine the thread was calibrated wrong the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Ref#: 00-8755-040-01 lot#: 2948866 - yield: 99 - delivered: 99 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: funktional : jammed event description: it was reported that during the revision surgery surgeon was unable to remove the biolox delta head (ref: 00-8775-040-01) from the avenir müller stem (ref: 01.06010.003).Therefore he had to remove the stem as well as the head.The reason of the revision surgery was due to migration of the maxera cup 7 days after the primary op.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.- the compatibility check was performed and showed that the product combination was approved by zimmer biomet.- review of inspection pan.- review of surgical technique.Conclusion summary: review of the device history records for the product did not identify any deviations or anomalies related to the reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).Products were not returned for detailed examination.Inspection plans of the devices confirm that the respective characteristics were inspected thoroughly.Therefore, it can be excluded that a manufacturing error favored or contributed to the reported event of seized implants.It is possible that an uncleaned surface of the stem taper might have led to being stuck of the head on the stem.However, without the products to examine it is not possible to find a root cause of the reported failure.Based on the given information the complaint could not be confirmed and we were not able to identify a specific root cause for this issue.However, the risk of difficulty in removing the head from the stem is covered in the risk management work-sheet.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)(6).Note: the following case is associated with this incident (same patient): (b)(6) the following reports are associated with this event: 0009613350 - 2019 - 00112 - 1.

Event Description

Investigation results are now available.

• Brand Name: BIOLOX DELTA HD 12/14 40X-3.5
• 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: 8399290
• MDR Text Key: 138101979
• Report Number: 0009613350-2019-00113
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430396
• UDI-Public: 00889024430396
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-040-01
• Device Lot Number: 2948866
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• 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