MAUDE Adverse Event Report: BIOMET, INC. BIOLOX DELTA CERAMIC HEADS 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number 12-115121

Device Problems Crack (1135); Fracture (1260); Material Fragmentation (1261); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 01/14/2019

Event Type  malfunction  

Event Description

Excerpts from surgeon's operative note: final stem placed in the proximal femur and seated.Cleansed the femoral trunnion and impacted the final ceramic head onto the femoral trunnion.As we did this it appeared to have solid cold weld.I went to reduce the hip and when i placed my finger on the femoral head i realized that there was a crack within the femoral head.Then externally rotated the hip again and realized that the femoral head ceramic head fractured.The anterior two-thirds of this head was cold welded to the femoral trunnion and the posterior one third had a loose fragment.There were several other fragments noted.We removed all fragments that we could identify.I actually had to use a square-ended impactor to dislodge the anterior two-thirds of the ceramic head from the femoral trunnion.I "place" lighted retractors in and around the acetabulum and we checked the acetabular liner and soft tissue for any further debris.There was no marking or scoring of the polyethylene liner.There were 2 fragments of ceramic head that were removed.We tried to reconstruct the ceramic femoral head on the back table and it appeared that we had all fragments.I utilized fluoroscopic guidance and no further fragments of ceramic were identified.We irrigated the wound with sterile normal saline 3 l.I again placed retractors and looked for any further fragments and none were found.Cleansed and dried the femoral trunnion; there was no deformity of the femoral trunnion identified.The biolox option ceramic femoral head with a +3 mm neck length was then impacted onto the femoral trunnion with solid cold fit.No fractures of this component were noted.We again checked the acetabulum for debris and none was found.We reduced the hip and again tested for stability and it was found stable.Post op x-ray taken in pacu revealed a retained foreign body.Patient was informed & returned to surgery.Excerpt from surgeon's 2nd operative note: fluoroscopic guidance; we rotated the hip and under a rotation view you could see that there was a small fragment radiopaque next to the femoral trunnion.Looked down into the joint and evacuated hematoma.I could not see this fragment of ceramic and had to utilize fluoroscopy to identify it.I was then able to remove it utilizing a pituitary roger.Irrigated the hip with sterile normal saline.We took multiple fluoroscopic images of the hip in multiple planes and did not see any further radiopaque material foreign body.The wound was copiously lavaged with sterile normal saline.Patient was discharged without further incident.Manufacturer response for 12-115121 modular ceramic head, metal on polyethylene, 36mm, (brand not provided) (per site reporter).Manufacturer wishes to take possession of the device for testing and evaluation.

• Brand Name: BIOLOX DELTA CERAMIC HEADS 36MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET, INC.; 56 east bell dr.; p.o. box 587; warsaw IN 46582
• MDR Report Key: 8276997
• MDR Text Key: 134135308
• Report Number: 8276997
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12-115121
• Device Catalogue Number: 12-115121
• Device Lot Number: 2968724
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 124