MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Ambulation Difficulties (2544); Muscle/Tendon Damage (4532)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: shell with cluster holes porous 52 mm o.D.Size ii for use with ii liners catalog#: 00875705201; lot#: 64108413.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 10 standard offset catalog#: 00771101000; lot#: 64562106.Neutral liner 36 mm i.D.Size ii for use with 52 mm o.D.Size ii shell catalog#: 00885101036; lot#: 64552127.Therapy date: (b)(6) 2020.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.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.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to pain, difficulty ambulating and tissue damage.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that patient (id: (b)(6) taking part in the mymobility clinical study had an initial right tha on (b)(6) 2020.The patient was revised on (b)(6) 2020 due to pain, difficulty ambulating, and tissue damage.The surgeon reported that there was nothing wrong with the screws themselves, they were just placed in a position that was causing soft tissue irritation and were, therefore, removed.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Study report mymobility: mymobility clinical study patient id: (b)(6), female, born on (b)(6) 1957, height 162, 50 cm, weight 48, 50 kg, bmi: 18,30.Significant past medical history: osteoarthritis, thyroid disease, contralateral hip in 2016.On (b)(6) 2020: pre-op health score ¿ 80.No intra-operative compilations identified.D/c home with aspirin for dvt prophylaxis.Participant changed their mind and requested home health pt and mymobility.On (b)(6) 2020 (1-month visit): full weight bearing with antalgic gait.Pain ¿ buttock shooting (radiating) down the leg.Limb length ¿ equal.Health score ¿ 51, neutral-satisfied.On (b)(6) 2020 (3-month visit): full weight bearing with antalgic gait.Good rom, no pain on physical exam, limb lengths are equal.Moderate pain, moderate problems walking.Health score ¿ 80.I had hematoma in the surgical area which caused swelling and severe pains on the right hip and leg.Taking oxycodone caused nausea, shortness of breath.The hematoma was not excised.This was a ed diagnosis.This could be possibly be related to the ct findings of screw protrusion found later on (b)(6) 2020.The patient would have been cleared of all anesthesia products.Some patients are more sensitive to pain medications and can display a wide range of reactions and sensitivities.Radicular symptoms consistent with l5 nerve root compression.Not related to the device or procedure.Usual causes are ddd, stenosis, spondylolisthesis, or compression fracture.Degeneration of lumbar intervertebral disc, lumbar radiculopathy.Not device or procedure related.On (b)(6) 2020: persistent right hip pain.On (b)(6) 2020: ct hip w/o iv contrast.On (b)(6) 2020 (6-month visit): i have severe problems in walking about.I have severe pain or discomfort.Health score ¿ 40.On (b)(6) 2020: right hip revision, removal of hardware.Painful right tha.Spinal plus mac anesthesia, ebl 150 ml.X-rays at the time of surgery showed good hardware alignment without complication.Ct scan showed the most superior screw went through the superior cortex of the ilieum and was likely irritating the iliopsoas muscle belly.Fluid cultures sent (no report).Fluid not consistent with infection.Surgical report: revision report, date of service on (b)(6) 2020: x-rays at the time of surgery showed good hardware alignment without complication.However, postop follow-up films of slightly different angle showed possible screw penetration beyond the cortical rim of the pelvis and a ct scan was obtained and this showed that the most superior screw went through the superior cortex of the ilium and was likely irritating the iliopsoas muscle belly.We began with surgical incision along the previous scar.We debrided scar tissue from the anterior and superior rim of the acetabulum.We then removed the acetabular liner using osteotomes and removed both acetabular screws.The acetabular component was osseointegrated.Impaction of a new liner and trial reduction with a 36 +0 head.Mounting of a biolox option 36 +0 head.Closure.X-rays: in total 7 x-rays, reported to have been taken on (b)(6) 2020, have been received.The reported screw protrusion can be confirmed based on the provided radiographs.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that patient (id: (b)(6) taking part in the mymobility clinical study had an initial right tha on (b)(6) 2020.The patient was revised on (b)(6) 2020 due to pain, difficulty ambulating, and tissue damage.The surgeon reported that there was nothing wrong with the screws themselves, they were just placed in a position that was causing soft tissue irritation and were, therefore, removed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Investigation revealed that the incorrect screw placement (protrusion of the screw) caused tissue irritation and pain, which led to revision surgery.The biolox head was replaced during revision to restore the biomechanics of the joint with a smaller offset.Thus, there was no device problem of the biolox head.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

No change to previously reported event.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11019487
• MDR Text Key: 221784580
• Report Number: 0009613350-2020-00594
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: 00889024430358
• Combination Product (y/n): N
• PMA/PMN Number: K071535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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: 00-8775-036-01
• Device Lot Number: 3013180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 49