MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SIZE 6 TMZF STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Device Damaged by Another Device (2915)

Patient Problems Pain (1994); Injury (2348)

Event Date 03/24/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that: "on (b)(6) 2007, the patient underwent a right total hip replacement surgery.It was further reported that "the patient experienced persistent groin pain and a pinching feeling, which ultimately revealed neck impingement of the neck of the cup; requiring a revision surgery on (b)(6) 2009." this pi is for revision of primary.

Event Description

It was reported that: "on (b)(6) 2007, the patient underwent a right total hip replacement surgery.It was further reported that "the patient experienced persistent groin pain and a pinching feeling, which ultimately revealed neck impingement of the neck of the cup; requiring a revision surgery on (b)(6) 2009." this pi is for revision of primary.Update as per op report: there were black markings on ceramic head suggestive of wear debris.

Manufacturer Narrative

An event regarding range of motion involving an unknown stem was reported.The event was confirmed by clinicians review.Method & results: product evaluation and results: a visual, functional and dimensional inspection was not performed as the device was not returned for analysis.Clinician review: a review of the provided medical records by a clinical consultant revealed: "on (b)(6) 2007 he underwent a right total hip arthroplasty.On (b)(6) 2007 for an i & d of the right hip with cultures due to a painful, swollen right hip.At the time there was no evidence of "component malfunction".On (b)(6) 2007 the patient complained of pain and stiffness of the right hip, but was discharged home with a walker.A subsequent office visit of (b)(6) 2007 is noted to be the first post-operative visit following i&d of the right hip.It is noted that the staples were removed with "no signs of infection or inflammation".Medical records of other procedures include an injection of a right trochanteric bursa with steroids and local anesthesia under fluoroscopy on (b)(6) 2008.On (b)(6) 2008 the patient underwent a right trochanteric bursectomy for which the operative note describes general anesthesia and a diagnosis of chronic trochanteric bursitis.On 2008 "no problems post-op" is noted.The impression was "iliopsoas tendinitis or crack or defect in ceramic liner or anterior cup impingement".Exploration surgery was suggested.On (b)(6) 2008 a right arthroscopic iliopsoas release was performed for a diagnosis of iliopsoas tendinitis.(b)(6) 2008 he was pre-op tendon release and on (b)(6) 2009 continued right hip pain was noted.(b)(6) 2008 he complained of pain in the right hip and was to consider exploratory surgery.On (b)(6) 2009 a revision of the right total hip was performed for right hip pain, status-post total hip arthroplasty.It was noted that the patient complains of "pinching feeling in groin".The findings included neck impingement on the neck of the cup.Black markings on ceramic head" was noted.One-half hour post-operative a gram stain report was "1 + organisms" and the patient was begun on antibiotics.On a post-operative visit of (b)(6) 2009 the staples were removed and no sign of inflammation or infection were noted.Product history review: a review of the product history records could not be performed as the device was not properly identified.Complaint history review: a complaint history review could not be performed as the device was not properly identified.Conclusions: the event was confirmed as per clinicians review.A reviewed of provided medical records by consultant clinician revealed that, "on (b)(6) 2009 a revision of the right total hip was performed for right hip pain, status-post total hip arthroplasty.It was noted that the patient complains of "pinching feeling in groin".The findings included neck impingement on the neck of the cup.In this case of subclinical infection of the right total hip arthroplasty initially treated with i&d early post-operative primary surgery and later with a positive gram stain at revision, pain appeared related to trochanteric bursitis, acetabular impingement, and possible infection.Repositioning the acetabular component into anteversion apparently resolved the impingement problems and also the possible iliopsoas tendinitis.No examination of the explanted components is available.Black markings described on the alumina head are consistent with repeated subluxations.There is no evidence that factors of faulty prosthetic design, manufacturing, or materials were responsible for this clinical situation." no further investigation for this event is possible.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN SIZE 6 TMZF STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7960088
• MDR Text Key: 123510507
• Report Number: 0002249697-2018-03304
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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: 09/14/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 95