MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 the patient was implanted a biolox delta, ceramic femoral head, m, 28/0, taper 12/14 on an unknown side on an unknown date and it was not possible to move the head in the liner.

Manufacturer Narrative

No trend considering the following event is identified: head is stiff in the liner.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: a biolox® delta, ceramic femoral head 28/0 (ref: 00-8775-028-02 lot: 2895202) has been received.It has been reported that after insertion the head was stiff in the liner and did not move.No medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis - visual examination: the returned product shows the biolox® delta, ceramic femoral head in the ringloc bipolar component, the femoral head is stuck in the liner.The liner and the cup show no considerable damage on the outside area.Inside the ceramic head metal marks are visible, a possible root cause could be that during the operation a instrument was inserted into the head taper, which caused the metal marks.- measurements: because the ceramic head is stuck in the liner it is not possible to measure the size of the head.As the label is visible the size of the outer diameter is 28mm which is the right size to fit in the liner.Further, the dhr for the head indicates that all components met all specifications.- functional test: a functional test was performed by trying to move the head in the liner.Applying a high force on the rim area of the head, the head moved slightly, but not as intended.It was possible to move the head so that the lms is visible.Further to see if there are marks on the head, from a possible debris between liner and head, the head was turned to see the articulating surface.The outer surface shows no damage or imperfections.Based on this functional test the reported event can be confirmed.Review of product documentation - the compatibility check was performed from (b)(6) and showed that the product combination was approved by zimmer biomet.- inspection plan: - characteristic no.1 feature ¿diameter ( 40 0/-0.065)".With scope of testing: 100%.Means of inspection: "cmm" - characteristic no.3 feature ¿surface profil (0.005)".With scope of testing: 100%.Means of inspection: "cmm" - characteristic no.4 feature ¿ra 0.02 polished".With scope of testing: 100%.Means of inspection: "cmm" root cause analysis root cause determination using dfmea: - limitied range of motion, impingement of components due to inappropriate design concerning range of motion => not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Further, the verification report: "zimmer heads and stems range of motion analysis on ringloc bi-polar liners", confirms the compatibility of zimmer heads with the ringloc bi-polar liners.- increased wear due to foreign particles in cop and coc pairing
=
> possible, as the visual examination cannot exclude any kind of foreign material on the polyethylene part.- wrong combination of the components due to lms marking is not readable under or lighting, marking parameters are not sufficient enough => not possible: as the lms of the ceramic head is clearly visible and the ceramic head and the liner reported are compatible.- reduced performance of material due to resterilization by the user (off label use) => possible: it is unknown if the product was resterilized or not (off-label use).- mal-function of tha (wear, fracture, dislocation etc.) due to off label use, combination with competitor products => not possible: the compatibility check was performed from (b)(6) and showed that the product combination was approved by zimmer biomet.Conclusion summary based on the returned product and the given information the complaint could be confirmed.The visual examination and the functional tests did confirm that the ceramic head is stiff in the liner.With a high force applied on the head it can be moved, but not with the intended rom.It remains unclear why the head is stiff/ cannot move freely in the liner.The visual examination/ functional test showed no debris/ wear between head and liner.However as it is not possible to remove the head from the liner without the corresponding extraction instrument, it cannot be investigated if something is stuck under the head/on the poly insert.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The compatibility check was performed from (b)(6) ("zimmer femoral stems and heads on biomet ringloc bipolar hip system") and showed that the product combination ceramic femoral head 28/0 (ref: (b)(4)) and ringloc bipolar 28x46mm (ref.110010465) is approved by zimmer biomet.The role of the bi-polar liner regarding this reported event will be investigated within (b)(4), by zimmer inc., warsaw.Therefore, 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 (b)(4) considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, 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
• 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: 6878276
• MDR Text Key: 86702707
• Report Number: 0009613350-2017-01297
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• 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: 00-8775-028-02
• Device Lot Number: 2895202
• Other Device ID Number: 00889024430297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2017
• 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