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

Catalog Number UNK_JR

Device Problems Degraded (1153); Unstable (1667)

Patient Problems Pain (1994); Joint Dislocation (2374); Numbness (2415)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

An event regarding fretting/debris and instability involving an unknown shell 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: no medical records were received for review with a clinical consultant.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: it was reported that the patient has had four anterior dislocations of the right hip since the revision and the patient began developing tremor in the hands and dulled dexterity, poor balance, forgetfulness, increased irritability, diminished pain tolerance, fatigue, and visual disturbances, balance issues, mood disorder, and memory problems.Numbness and tingling in the hands, and general and focal hypometabolism in a pattern consistent with chronic toxic encephalopathy were also reported.The event cannot be confirmed and the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of the device, pathology reports, pre- and post-operative x-rays and the primary 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.Device not returned.

Event Description

As reported in medwatch report mw5092687: "the right hip was revised from the [competitor] articulation to a stryker restoration acetabular wedge augment shell (ras) with a 36mm internal liner and a +12 ceramic head with a titanium sleeve on the existing stem.The patient has had four anterior dislocations of the right hip since the revision.The instability of his right tha likely due to the loss of periprosthetic tissue from reaction to metallic debris.He began developing tremor in the hands and dulled dexterity, poor balance, forgetfulness, increased irritability, diminished pain tolerance, fatigue, and visual disturbances.Balance issues, mood disorder, and memory problems.He had been taking medicine for pain on a semi-regular basis.Numbness and tingling in the hands.General and focal hypometabolism in a pattern consistent with chronic toxic encephalopathy.".

• Brand Name: UNKNOWN RAS SHELL
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9849340
• MDR Text Key: 186683603
• Report Number: 0002249697-2020-00536
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2020

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/18/2020
• 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