MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Dislocation (2374); Numbness (2415); Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10- hip-unk-stem-unk, item #unknown, lot #unknown.Constrained liner - 10 degree oblique face 32 mm i.D.For use with 50/52/54 mm o.D.Shells with constraining ring, item# 00615405032, lot# 64100289.Shell porous with cluster holes 54 mm o.D, item# 00620005422, lot# 62740870.G2 - brazil.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported a patient underwent a left hip revision approximately three years and three months¿ post implantation due to a dislocation.The head, shell and liner were removed and replaced.Attempts have been made and no further information is available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information the following sections were updated: b4, b5, d9, d10, g3, g6, h1, h2, h3, h6, h10.The biolox head was returned for investigation.Metal transfer marks are visible on the articulating surface, particularly on one side halfway between the bevel and the highest point of the head.The bevel of the biolox also show metal transfer marks and on one side a consistent halo is visible.Metal transfer patterns (seating pattern) can be seen on the taper surface.A review of the device manufacturing records confirmed no abnormalities or deviations.Device used for treatment.Medical records were provided and reviewed by a healthcare professional.A review of the available records identified the following: in the spring of 2023, the patient dislocated while sitting on the toilet and experienced pain; descended stairs while dislocated.Unable to reduce hip, scheduled for revision in the spring 2023 but was delayed 1 day due to product.Had negative bacterial growth after 24 hours.Revision in the spring 2023; removed shell, liner, ring, and head but no mention of explant of stem.A review of medical records also noted "dislocation of the left hip prosthesis due to failure of osteosynthesis material." however, based on the third-party review, no lucency, radiolucency, or failure to osteointegrate was confirmed from the provided x-rays.Radiographs were provided and reviewed by a radiologist.A review of the available records identified the following: overall size of the implant is appropriate.Left acetabular cup inclination angle: 45 degrees.Femoral head superior dislocation is seen.No liner fracture was seen.A constrained acetabular cup liner is seen.No contributing factors are definitely identified.Of note, the documentation does not report any competitor product involved in this event with the available information a femoral head dislocation can be confirmed; nevertheless, a definitive root cause cannot be determined.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 16972780
• MDR Text Key: 315665734
• Report Number: 0009613350-2023-00205
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2023

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: 00877503202
• Device Lot Number: 2991000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 06/15/2023; 08/11/2023
• Supplement Dates FDA Received: 06/30/2023; 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 120 KG