MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-ray for review.Where lot numbers were received, 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 has been experiencing an allergic reaction, swelling and pain.

Event Description

Please refer to report 0009613350-2019-00445.

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 trigger considering the following event is identified: allergic reaction.Event description: it was reported that a biolox delta head and an alloclassic sl stem were implanted on (b)(6) 2010 in the right hip along with other warsaw design components and that the patient is being monitored due to pain, itching and swelling resulting from a possible allergic reaction.Patient has been tested positive for nickel allergy.Review of received data: patient call report received dated (b)(6) 2019.Patient symptoms have been listed as well as positive testing to nickel allergy.Patient has not been tested for infection.Patient information given.Device 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.Raw material certificate for alloclassic stem and biolox delta head reviewed.Chemical composition for both devices within tolerance and none of the products contain the chemical element nickel (ni).Sterilization certificate reviewed and sterilization for both devices and their respective lots can be confirmed.Conclusion: the investigation results did not identify a non-conformance or a complaint out of box (coob).The reported nickel allergy is neither due to the alloclassic stem nor due to the biolox delta head as nickel is not included in the material composition.The alloclassic stem is composed of the following material and the recommended testing methods:ti-6al-7nb alloy - wrought or forged.The biolox delta head is composed of the following material: alumina (aluminum oxide), zirconia (zirconium oxide), chromium oxide.The sterilization certificate has been reviewed and both products with their respective lots have been confirmed to have been sterilized.Therefore, based on the given information, the event can not be confirmed.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).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14
• Type of Device: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8780437
• MDR Text Key: 150697500
• Report Number: 0009613350-2019-00445
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: 00889024430327
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-02
• Device Lot Number: 2535766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 76