MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CONE BODY 20; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problem Corroded (1131)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 09/15/2023

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.

Event Description

Surgeon contacted the sales rep with an x-ray of a patient he operated on in 2009.It is a restoration modular insitu.He did not provide any patient details, nor implant specifics.The patient is symptomatic and has come back for review.He believes there may be some corrosion at the junction of the proximal body and distal stem which has caused lysis.This is the only information he supplied.

Manufacturer Narrative

Reported event: an event regarding osteolysis and corrosion involving an unknown modular body was reported.The event for osteolysis was confirmed via medical review.Method & results:  device evaluation and results: not performed as product remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: the event descriptions from the product inquiry summary states: surgeon contacted me with an x-ray of a patient he operated on in 2009.It is a restoration modular insitu.The patient is symptomatic and has come back for review.He believes there may be some corrosion at the junction of the proximal body and distal stem which has caused lysis."the surgeon is planning a revision on this patient, date unknown.The junction between the cone body and upper body looks like the gap is slightly bigger.Thigh pain the ap x-ray shows a tha with a restoration modular stem.There is significant demineralization of the bone with expansion of the cortex in the region of the taper.This is consistent with lysis related to wear debris.It is confirmed that a revision that a tha failure due to osteolysis about the region of a restoration modular stem taper connection occurred.The root cause of this failure cannot be determined from the documentation provided.Should additional information become available i would be happy to further this assessment.Device history review: could not be performed as lot code information was not provided.  complaint history review: could not be performed as lot code information was not provided.  conclusion: it was reported that the patient has an upcoming revision due to osteolysis and corrosion.A review of the provided medical records by a clinical consultant indicated: the event descriptions from the product inquiry summary states: surgeon contacted me with an x-ray of a patient he operated on in 2009.It is a restoration modular insitu.The patient is symptomatic and has come back for review.He believes there may be some corrosion at the junction of the proximal body and distal stem which has caused lysis.Update: "the surgeon is planning a revision on this patient, date unknown.The junction between the cone body and upper body looks like the gap is slightly bigger.Thigh pain the ap x-ray shows a tha with a restoration modular stem.There is significant demineralization of the bone with expansion of the cortex in the region of the taper.This is consistent with lysis related to wear debris.It is confirmed that a revision that a tha failure due to osteolysis about the region of a restoration modular stem taper connection occurred.The root cause of this failure cannot be determined from the documentation provided.Should additional information become available i would be happy to further this assessment.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative and the revision operative report as well as patient history and follow-up notes 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

Surgeon contacted the sales rep with an x-ray of a patient he operated on in 2009.It is a restoration modular insitu.He did not provide any patient details, nor implant specifics.The patient is symptomatic and has come back for review.He believes there may be some corrosion at the junction of the proximal body and distal stem which has caused lysis.This is the only information he supplied.Update: "the surgeon is planning a revision on this patient, date unknown.The junction between the cone body and upper body looks like the gap is slightly bigger.Thigh pain.".

• Brand Name: UNKNOWN CONE BODY 20
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17907114
• MDR Text Key: 325338965
• Report Number: 0002249697-2023-01170
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 75 KG