MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M 32/0, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 01/09/2014

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.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.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.This is a split complaint with zimmer inc.(b)(4) reported on (b)(4).Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a biolox delta, ceramic femoral head, m, 32/0, taper 12/14 on (b)(6) 2013.The patient underwent a procedure to remove scar tissue and adhesions approximately four months post implantation after experiencing pain, slippage and instability.No devices were removed.

Manufacturer Narrative

As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is cmp(b)(4).

Event Description

It was further reported that the biolox delta, ceramic femoral head was revised due to pain and instability on (b)(6) 2014.

Manufacturer Narrative

No trend considering the following event is identified: instability.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that patient underwent total hip procedure on (b)(6) 2013 and experienced pain, slippage and instability due to scar tissue and adhesions.The first surgery was (b)(6), 2014 and removed scar tissue, no devices were removed.- no medical data such as x-rays, surgical notes or any other case-relevant documents received.- no product was returned to zimmer biomet for in-depth analysis as the device was not explanted.- the compatibility check was performed from (b)(6) and showed that the product combination was approved by zimmer biomet.Root cause analysis root cause determination using dfmea(biolox head): - mal-function of tha (wear, fracture, dislocation etc.) due to wrong size of head diameter and/or offset, wrong taper size combination not possible: correct combination was done.- mal-function of tha (wear, fracture, dislocation etc.) due to off label use, combination with competitor products not possible: the used components are from zimmer biomet.- loss of connection due to inadequate assembling procedure possible: no surgical report was provided.It is unknown which steps were done in the surgery.Conclusion summary it was reported that patient underwent total hip procedure on (b)(6) 2013 and experienced pain, slippage and instability due to scar tissue and adhesions.The first surgery was (b)(6), 2014 and removed scar tissue, no devices were removed.As no devices were removed, no devices were available for the investigation.Therefore the condition of the components is unknown.Neither x-rays, operative notes nor office visit notes were received.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was yet reported, that during the surgery of (b)(6), 2014, scar tissue was removed only.No devices were removed.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M 32/0, TAPER 12/14
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6543309
• MDR Text Key: 74357021
• Report Number: 0009613350-2017-00612
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2017

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: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-02
• Device Lot Number: 2697053
• Other Device ID Number: 00889024430327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided; 09/12/2017
• Supplement Dates FDA Received: 05/23/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 89