MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 06/05/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and is currently not available.The manufacturer did not receive the device for investigation.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

It was reported that the patient was implanted a biolox delta, ceramic femoral head, m, 36/0, taper 12/14 on (b)(6) 2014 on the right hip and the patient underwent revision surgery on (b)(6) 2015 due to chronically infected hip with severe metallosis.

Manufacturer Narrative

Investigation results were made available.Additional: b7, h2 correction: b4, g4, g7, h3, h6, h10 device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analyis: no trend considering the following event is identified:infection review of event description: it was reported that a patient with long medical history with several surgeries on his right hip has been having a revision surgery due to chronic infection of the right hip.This is a split case, for devices manufactured by zimmer inc., see cmp-0329501 (0001822565-2017-07049).The patient had long history of pain and underwent right tha; patient experienced 3 discloation and was subsequently revised; afterwards, the patient experienced infection of this hip and was revised again.Patient is now with propably chronic infected hip.Medical history with his right hip: - 3,5 months post implantation dislocation with closed reduction (this case is filed under cmp-0352196 and for devices manufactured by zimmer inc., warsaw see cmp-0352771).- second dislocation 1 year post implantation (this case is filed under cmp-0352207 and for devices manufactured by zimmer inc., warsaw see cmp-0352784).- revision surgery after third dislocaiton (this case is filed under cmp-0352218 and for devices manufactured by zimmer inc., warsaw see cmp-0352785) - 13 days post implantation the patient was reviesed again due to infection (this case is filed under cmp-0352237 and for devices manufactured by zimmer inc., warsaw see cmp-0352787) - around 1 year post implantation a surgery for irrigation and debridement due to swelling and a small lump was performed (this case is filed under cmp-0352242 and for devices manufactured by zimmer inc., warsaw see cmp-0352789).- after the perfromed debridement and irrigation he went to see the doctor again due to progressively increasing pain.Impression of a chronic coag negative staph infection, right total hip.A revision surgery was scheduled for the next two weeks (this case is filed under cmp-0352262 and for devices manufactured by zimmer inc., warsaw see cmp-0352791).Review of received data - surgical report, dated june 5, 2015 preoperative diagnosis: chronically infected right total hip.Postoperative diagnosis: same, with severe metallosis tight hip.Procedure: deep irrigation and debridement of chronically infected tight thp.Debridement of extensive metallosis.Revision of the femoral head and the acetabular liner.Idications (summary): 64 y old patient had 2 or 3 years ago a right thp.He did well, but then had probelems with dislocations and underwent therefore a revision surgery.Afterwards, he had no further dislocation, but 2 weeks post-op he presented with bloody drainage.He undewent therefore a surgery to wash out and hematoma evacuation.Intraoperative culutres grew coag negaitve staph.Therefoe he was treated for 6 weeks with iv antibiotics.After few months he began having pain and swelling, and erythema.He was treated again with antibiotics, however still did not seem to be improving.Further surgical debridemnt was therefore recommended.Descibtion of the procedure (summary): during the surgery the old incision was reopened, a moderate amount of serosanguineous fluid that did not appear to be grossly infected was found.An extensive metallosis was also seen and upon further exposure it was detected that the femoral neck was impinging on the locking ring on the acetabular constrained liner at the 11 o clock position , there was erosion of the locking ring (of the line) and some notching of the neck.The femoral component and the femoral neck was found to be rigidly solid and stable in the bone , hence it was decided to be left in the bone.The acetabulum was exposed and found extensive metallosis everywhere which was meticulously debrided.Also any questionable material that appeared necrotic or possibly infected was sharply excised.The locking ring was removed from the constrained acetabular liner and then pried out the acetabular liner as well, there were two screws in the acetabular component and these were both removed and the 10 degree elevated rim polyethylene liner was tapped in.After the trial reduction of the head , the permanent ceramic head was tapped in.The patient was taken to the recovery room in stable and satisfactory condition.Doctor report, dated june 22, 2015 the reported states that patient has had problems with persisting drainage.The drainage seems to be serous.The wound was inspected and he has 1 small little pinpoint from where the drainage is coming from.A stick in this area was done, the rest of the wound was completely healed.He still sees an other doctore for going antibiotic management.Doctor report, dated july 6, 2015 the report states that the drainage has begund to slow up and over the last days he has hardly had any.He has daily iv antibiotics.He has a litte erythema.He is walking well.Satisfactory 1 month post-op status.As due to his hiv disease his white cell count is low and this does probably complicating his treatment.Many other doctor reports of this very well documented patient history were received.However the review of those with a summary oft it were done in the associated cases as part of the investigation and evaluation for that ones.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.According to the available information, the product location is unknown.Root cause analysis root cause determination using rmw: - non-sterile device is implanted due to sterilization process failure => not possible, the sterilization method is validated according to the sterilization specification.- non-sterile device is implanted due to contaminated device due to packaging failure => possible, the packaging of the product is validated according to the packaging specification.Nevertheless, one should check the product before opening the packaging regarding the existence of any imperfection/deformation.- non-sterile device is implanted due to surgeon resterilizes head => possible, ifu (chapter "warnings - single use only - do not re-use" and symbol on box label: "not to be re-used" is provided to customers.However, still it is not surely known whether the device was used before or not.- non-sterile device is implanted due to packaging is damaged due to inadequate handling during transportation, storage => possible, the handling of the device is out of zimmer biomet control.- non-sterile device is implanted, cross contamination due to explanted ceramic head is reused with the same or new femoral stem => possible, ifu (chapter "warnings - single use only - do not re-use" and symbol on box label: "not to be re-used" is provided to customers.However, still it is not surely known whether the device was used before or not.- non-sterile device is implanted, cross contamination due to inappropriate information on packaging label or not legible packaging label leads to incorrect use of implant (e.G.Use of expired product, resterilization of head) => possible, ifu chapter "warnings - single use only - do not re-use" and symbol on box label: "not to be re-used" is provided to customers.However, still it is not surely known whether the device was used before or not.Conclusion summary: a patient underwent a revision 1 year and 3 months post implantation due to chronically infected right hip.During the surgical intervention massive metallosis was found.The metallosis origin from impingement of femoral neck and locking ring of the acetabular liner, there was also erosion seen of the locking ring and some notching of the neck (of the stem).Since the metallosis is related to the zimmer incs., warsaw devices it will not be evaluated in the case at hand.For the zimmer inc., warsaw case see cmp-0329501.The gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot has been reviewed and was found to be according to specification.Therefore, it can be excluded that an unsterile device caused the infection.Moreover, no trend on infection has been observed for this product.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.It is highly unlikely that a disadvantageous product design favored or contributed to the infection.However, the ifu for endoprosthesis states that ¿early or late infections¿ are ¿possible consequences of an implant¿ and should be considered when implanting zimmer biomet devices.Nevertheless, possible causes of infection include wrong handling of device due to wrong information, wrong resterilization procedures for sterile delivered parts or packaging failure during transportation.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 gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, 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
• MDR Report Key: 7132980
• MDR Text Key: 95323761
• Report Number: 0009613350-2017-01808
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-02
• Device Lot Number: 2719379
• Other Device ID Number: 00889024430365
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR