MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD V40 TAPER VIT HEAD; IMPLANT

Catalog Number 6260-5-132

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 11/23/2010

Event Type  Injury  

Event Description

Maude report, (b)(4), reported: volun (b)(6) 2014: had a hip replacement due to osteopathic (deteriorating joints).So on (b)(6), 2010 i had the hip replacement surgery.I have suffered severed chronic pain, muscle loss, burning sensation, sharp and dull pain constantly, disfigurement due to muscle loss.I also suffer from a disease called reflex sympathetic dystrophy (rsd), also know as crsp, so now the doctors i've seen also agree that the rsd had set in along with this stryker hip i have implanted is being recalled.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown total hip.An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

The patient is (b)(6).An event regarding patient pain involving a metal femoral head was reported.The event was confirmed.Medical records received and evaluation: clinician review of the provided records concluded: "the patient has documented reflex sympathetic dystrophy of the upper and lower extremities, along with other non-prosthetic related problems.Communication from stryker regulatory dated may 9, 2014 indicates the total hip arthroplasty components implanted in this patient are not part of a recall.There is no indication that this patient¿s symptomatic complaints are related to her total hip arthroplasty components." device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.The device is not part of a recall.Complaint history review was not performed as no device specific failure modes were identified.The investigation determined the root cause of the patient's symptoms to be reflex sympathetic dystrophy of the upper and lower extremities, unrelated to the implanted devices.Conclusions: clinician review of the provided records determined the root cause of the patient's symptoms to be reflex sympathetic dystrophy of the upper and lower extremities, unrelated to the implanted devices.The following other devices were added in this report: trident hemispherical cluster hole shell; cat # 502-11-54e; lot # 34586002.A 6.5 cancellous bone screw 35mm; cat # 2030-6535-1; lot# mjp3e7.Trident 0° x3 insert 32mm id; cat # 623-00-32e; lot # mjp6rk.Accolade 132 size 2.5; cat # 6020-2530; lot # 34658001.It cannot be determined which, if any of these devices may have caused or contributed to the patient's pain.

Event Description

Maude report, (b)(4), reported: volun 03-feb-2014: had a hip replacement due to osteopathic (deteriorating joints).So on (b)(6), 2010 i had the hip replacement surgery.I have suffered severed chronic pain, muscle loss, burning sensation, sharp and dull pain constantly, disfigurement due to muscle loss.I also suffer from a disease called reflex sympathetic dystrophy (rsd), also know as crsp, so now the doctors i've seen also agree that the rsd had set in along with this stryker hip i have implanted is being recalled.

• Brand Name: 32MM STD V40 TAPER VIT HEAD
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ 07430 NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3709976
• MDR Text Key: 4245213
• Report Number: 0002249697-2014-00961
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2014

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: Lay User/Patient
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 6260-5-132
• Device Lot Number: 34619202
• Other Device ID Number: STERILE LOT# 1008WCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 03/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2010
• 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: 52 YR
• Patient Weight: 74