MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 44MM CERAMIC HEAD; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 06/03/2011

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

This pi is for the revision of primary on (b)(6) 2011.As reported: "the doctor revised a total hip - the liner, head and sleeve from a 44 to an mdm due to dislocation.The original surgery date was unknown, however a revision surgery was done on (b)(6) 2011 to address a loose cup." spoke to rep regarding the (b)(6) revision.Patient has had a stryker stem since the prior implantation and rep is very certain the revised construct consisted of stryker devices.The rep and surgeon cannot confirm this as records prior to the 2011 revision do not exist, but based on the existence of the stryker stem (and head, which had been revised in 2011), both rep and surgeon have high confidence there was a revision of stryker devices.A 56mm shell, 2 fractured screws, liner, and morse taper ceramic head were revised to a 60mm shell with 3 screws, c-taper adapter sleeve, and 44mm biolox ceramic head with a 44f x3 0° liner.The stem was not revised.Rep does not have access to any additional information from the hospital or surgeon.

Manufacturer Narrative

An event regarding wear involving a unknown ceramic head was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: the patient underwent a primary left total hip arthroplasty for which no date of surgery, no operative report and no list of components are available.On june 2, 2011 he underwent a left hip revision with bone grafting of the acetabulum for a diagnosis of ¿failed left tha¿.The operative report describes spinal anesthesia and a posterolateral approach.The report notes, ¿ceramic head removed ¿ cup removed easily with kocher ¿ had two fractured screws ¿ not visualized ¿ had 56 cup ¿ reamed to 58 for 60 trident tritanium cup with three screws.A 44/0° x3 liner ¿ universal/c-taper 0 adapter sleeve and a 44 biolox ceramic head, universal, were implanted by uncomplicated surgery.¿ the patient was subsequently discharged on june 6, 2011.No patient demographics, no clinical or past medical history, no primary left total hip arthroplasty date or operative report, or examination of explanted components or serial x-rays are available.Based upon the information available for review, it is not possible to confirm the alleged loosening of the primary acetabulum, which was revised on june 3, 2011 or speculate as to the cause.-product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as patient demographics, clinical and past medical history, primary left total hip arthroplasty date, operative report, examination of explanted components and serial x-rays are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This pi is for the revision of primary on (b)(6) 2011.As reported: "the doctor revised a total hip - the liner, head and sleeve from a 44 to an mdm due to dislocation.The original surgery date was unknown, however a revision surgery was done on (b)(6) 2011 to address a loose cup." spoke to rep regarding the june 3 revision.Patient has had a stryker stem since the prior implantation and rep is very certain the revised construct consisted of stryker devices.The rep and surgeon cannot confirm this as records prior to the 2011 revision do not exist, but based on the existence of the stryker stem (and head, which had been revised in 2011), both rep and surgeon have high confidence there was a revision of stryker devices.A 56mm shell, 2 fractured screws, liner, and morse taper ceramic head were revised to a 60mm shell with 3 screws, c-taper adapter sleeve, and 44mm biolox ceramic head with a 44f x3 0° liner.The stem was not revised.Rep does not have access to any additional information from the hospital or surgeon.

• Brand Name: UNKNOWN 44MM CERAMIC HEAD
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8333735
• MDR Text Key: 135992102
• Report Number: 0002249697-2019-01025
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 03/25/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR