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

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: bone screw self-tapping 6.5 mm dia.30 mm length; catalog no #: 00-6250-065-30; lot #: 62292642.Constrained liner with constraining ring 36 mm i.D.Size mm for use with 60 mm o.D.Size mm shell; catalog no #: 00-8758-014-36; lot #: 63097134.Therapy date: (b)(6) 2020.The manufacturer did receive per for review.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 unknown side and underwent revision surgery due to instability and noise.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that patient underwent an initial hip arthroplasty on (b)(6) 2017 and was revised on (b)(6) 2020 due to squeaking noise and instability.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that patient underwent an initial hip arthroplasty on (b)(6) 2017 and was revised on (b)(6) 2020 due to squeaking noise and instability.Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore the condition of the components and their position in-vivo reamains unknown.Patient factors that may have affected the performance of the components such as activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.If and to what extent other possible factors might have been involved also remains unknown.Based on the available information the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific 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).The following reports are associated with this event: 0009613350-2020-00381, 0009613350-2020-00380, 0009613350-2020-00379.

• 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 SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10413358
• MDR Text Key: 203117715
• Report Number: 0009613350-2020-00381
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: 00889024430365
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 2909462
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2020
• 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