MAUDE Adverse Event Report: ZIMMER GMBH SULOX HEAD, L, 28/+3.5, TAPER 12/14

Model Number N/A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/14/2018

Event Type  Injury  

Manufacturer Narrative

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.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.  (b)(4).

Event Description

Ceramic head broke in a left hip without trauma.The implantation and explantation dates are left empty as the device involved in this complaint is broken.Hence, no expiration date is captured, for the same reason.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: ceramic head breakage.Event summary: it was reported that a ceramic head broke on (b)(6) 2018 in a left hip without trauma.Review of received data: 6 x-ray pictures were received: pelvic overview, left hip ap-projection: postoperative images with lying redone-drainage.Status after implantation of a cementless hip total endoprosthesis.No abnormalities, prosthesis stem orthograde, cup inclination angle about 42 degrees.Pelvic overview, left hip ap-projection: breakage of the femoral head, unchanged cup position, comparatively to the pre-x-ray, no change of findings in the stem area pelvic overview, left hip ap-projection: no visible changes of findings, femoral head in correct position.The surgery report of revision was received.Diagnosis: breakage of the ceramic head, inserted total hip endoprosthesis therapy: one-time change of ceramic head and pe inlay.Intraoperatively: in right side position skin incision through the existing scar with dilation.After visualization of the joint recognizable neocapsule with considerable scarring.Larger and smaller ceramic fragments are removed.The cone appears undamaged except for minor traces of wear.After ventralisation of the prosthetic cone knocking out the pe inlays.Subsequent removal of another ceramic fragments.The prosthesis cup showed no signs of loosening.Unspecifically described introduction of a new pe inlay and femoral head.Devices analysis: no product was returned to zimmer biomet for in-depth analysis, it was discarded.Review of product documentation: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Root cause analysis: root cause determination using dfmea: fracture of head due to fracture of head due to insufficient material thickness (wrong design): not possible: burst strength testing is validated.Loss of connection, fracture of ceramic head due to inappropriate design concerning pull-off/torque strength of the head on the stem taper: not possible: a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Loss of connection, fracture of ceramic head due to particles between stem and head taper: possible: there is no information available whether some particles were observed or not, no revision surgery report was available for review.Therefore cannot be excluded.Fracture of head to due stem taper corrosion (increasing of volume) due to wrong material pairing: possible: there is no information available whether some particles were observed or not, no revision surgery report was available for review.Therefore cannot be excluded.Mal-function of tha (wear, fracture, dislocation etc.) due to wrong size of head diameter and/or offset: not possible: no issue with size indicated.Mal-function of tha (wear, fracture, dislocation etc.) due to wrong material combinations: possible: the material combination is unknown, therefore cannot be excluded.Mal-function of tha (wear, fracture, dislocation etc.) due to off label use, combination with competitor products: possible: the material combination is unknown, therefore cannot be excluded.High wear, head fracture due to wrong raw material selection: not possible: raw material was checked.No deviations were noted.Loss of connection, fracture of ceramic heady due to use on a used or damaged stem taper: possible: no information regarding the stem was received, therefore cannot be excluded.Patient behaviour leads to premature failure due to inadequate information during patients counseling by surgeon: possible: it is possible that the patient did not follow the restrictions.Conclusion summary: it was reported that a ceramic head broke on (b)(6) 2018 in a left hip without trauma.The device was implanted on (b)(6) 2015 and revised on (b)(6) 2018 due to a ceramic head breakage.On the provided x-rays the breakage can be seen.The surgical report of explantation do not show any relevant information.There are several factors which could have contributed to the ceramic head breakage.A wrong patient behaviour can be the cause for the breakage or a malfunction of the tha.However, an exact root cause could not be determined.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).

Event Description

It was reported that the patient had a revision surgery approximately two years post implantation due to implant fracture.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: SULOX HEAD, L, 28/+3.5, TAPER 12/14
• Type of Device: SULOX HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7364850
• MDR Text Key: 103267912
• Report Number: 0009613350-2018-00368
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

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 Model Number: N/A
• Device Catalogue Number: 17.28.07
• Device Lot Number: 2818638
• Other Device ID Number: 00889024416963
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ALLOCLASSIC STEM, ITEM# 0100121080, LOT# 2796550; ANCHORAGE CAP, ITEM# 3534, LOT# 2816741; INSERT, ITEM# 3554, LOT# 2822646
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 125