MAUDE Adverse Event Report: ZIMMER GMBH SULOX, HEAD, S, 32/-3.5, TAPER 12/14; UNKNOWN

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Foreign Body In Patient (2687)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i.E.Biolox®-forte kopf 28/-3.5 's' 12/14; ref# (b)(4)) are marketed in usa, and therefore this report was filed.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, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted a sulox, head, s, 32/-3.5, taper 12/14 on (b)(6) 2012 on the right side.Patient suffered from pain and went to the doctor and had an x-ray.No known trauma.The patient underwent a revision surgery on (b)(6) 2016 due to pain and head breakage.Not all fragments of the broken head could be removed from the patient.

Manufacturer Narrative

Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.- event summary: (b)(6) male patient, with bmi (b)(6)and high activity level, received a thr on right side on (b)(6), 2012 and underwent a revision surgery on (b)(6) 2016 due to pain and breakage of the femoral head component.Review of received data - 1 x-ray dated (b)(6) 2012, taken 5 days after the implantation surgery shows the tha.Dark lines medially to the stem are observed.2 x-rays dated (b)(6) 2016, one being lateral view and the other ap view, show the right thr with the broken ceramic head.Femoral stem is observed to dislocated in the cranial direction.Ossification around the greater and lesser trochanter area is seen.Moreover, dark lines are visible medially to the stem starting from the neck region going down until the distal end.When this x-ray is compared with the one from the 2012 it can be said that the dark line adjacent to the stem medially around the lesser trochanter area hints to a possible loosening which have taken place.The x-ray dated (b)(6) 2016 shows the revised thr with the new head and inlay.Dark areas are visible medially to the stem.- primary implantation surgery report, dated (b)(6) 2012: operation: zimmer devices are implanted without any problem observed.20°adduction abd 30° internal rotation achieved.Post-op x-rays show good positions of the components.Revision surgery report, dated (b)(6) 2016: pre-op diagnosis: breakage of the ceramic head operation: previous scar incised.Ossifications around the hip joint and medially of the greater trochanter observed.Ceramic head noticed to be broken into 3 large fragments and many others small pieces.Due to sharp edges of the ceramic rupture the inlay is severely damaged.Inlay is removed after the calcifications are cleaned.The cup is fixed.Inlay of same size is inserted.The springring which fixes the inlay runs freely.A new ceramic head is impacted onto the existing stem.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.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 - fracture of head due to fracture of head due to insufficient material thickness (wrong design) => not possible: burst strength testing is validated.Moreover, a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation or in the current post market surveillance process.- loss of connection, fracture of ceramic head due to particles between stem and head taper => possible: during the implantation surgery it is possible that some particles left between the stem and head taper, therefore cannot be excluded.- fracture of head to due stem taper corrosion (increasing of volume) due to wrong material pairing => not possible: material pairing is approved by zimmer biomet.- mal-function of tha (wear, fracture, dislocation etc.) due to wrong size of head diameter and/or offset => not possible: size of head diameter is correctly selected.- mal-function of tha (wear, fracture, dislocation etc.) due to wrong material combinations => not possible: material combination is approved by zimmer biomet.- mal-function of tha (wear, fracture, dislocation etc.) due to off label use, combination with competitor products => not possible: material combination is approved by zimmer biomet.- compromized taper fixation strength, fracture of implant due to high patient activity, patient disregards limits of the device => possible: patient activity level is high.Moreover, it is not known whether the patient disregarded the limits of the device, therefore cannot be excluded.- loss of connection, fracture of ceramic head due to use on a used or damaged stem taper => possible: stem was not used before, however, it is not known if the stem was damaged during the operation.Therefore cannot be excluded.Conclusion summary the product was not received for the investigation.The review of the dhr indicates that the head met all requirements to perform as intended.Material certificate of the ceramic head confirms that the device was manufactured according to the product specifications.The possible reasons of the breakage are indicated in the root cause analysis.Moreover, it is indicated that the patient has (b)(6) which can be classified as over weight and the patient's activity level is also high, which might have contributed to the reported event.However, 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 other components of the thr are manufacture by zimmer inc (warsaw, indiana;usa) and were reported under cmp-(b)(4).The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is cmp-(b)(4).

• Brand Name: SULOX, HEAD, S, 32/-3.5, TAPER 12/14
• Type of Device: UNKNOWN
• 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: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6128385
• MDR Text Key: 60905099
• Report Number: 0009613350-2016-01376
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 17.32.05
• Device Lot Number: 2670331
• Other Device ID Number: 00889024416970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2012
• 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: 70 YR
• Patient Weight: 82