MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FMP HIP; FMP HEMISPHERICAL SHELL, 3 SCREWHOLE CLUSTER 56MM

Catalog Number 430-01-056

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Revision surgery - due to a complex pain pattern; osteolysis on zones 1 and 2 in the acetabulum with erosion of the stem seen on the lateral aspect of the cortex.Metal on metal hip.The patient's hip pain started 6 years ago, spontaneously.The patient went to the office experiencing numbness, pain, aching, and her hip felt like it was giving out.The pain was described as sharp in nature; localized to the inguinal area as well as the front and lateral aspect of the thigh.The pain gets exacerbated with weight bearing and leaves the patient unable to perform any activities of daily living.The pain is intermittent during the night and is also present without activity.

Manufacturer Narrative

The reason for this revision surgery was a complex pattern of pain, along with osteolysis of the acetabulum, after approximately 6.5 years in vivo.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records showed no non-conforming material reports associated with the main contributor component listed in the complaint.A review of the product complaint report history showed (b)(4) prior complaints against the fmp hemi shell part number 430-01-056.(b)(4) of these complaints specifically stated that the product itself had not failed.The remaining (b)(4) complaints (approximately one complaint per year) were for dislocation, loose shell, metal reaction, or migration of the shell.None of the prior complaints specifically mention pain or osteolysis.This is the (b)(4) complaint for the incident lot number.There is no information about any patient injuries, activities, accidents, or medical contraindications that may have contributed to revision surgery.An e-mail accompanying the product complaint form states that the patient's chromium level was 5.3 and cobalt level was 2.4, both annotated "h" (high).Two studies* indicate a chromium level of 5.3 g/l is indeed higher than expected for a metal-on-metal total hip arthoplasty (tha), by approximately 5-10x.A cobalt level of 2.4 g/l is within the expected range for a metal-on-metal tha.This patient's chromium level falls within the range typically seen when the acetabular component is malpositioned, so poor acetabular orientation is one possible root cause of this patient's symptoms.While "erosion of the stem" is mentioned in the complaint, it's unclear whether this is the result of an impingement with the acetabular components.Additional information, such as patient x-rays, would be required to reach a more definitive root cause conclusion.Bernstein m, gupta s, petit a, zukor dj, huk ol, antoniou j.The effect of operative factors on outlier ion levels in patients with metal-on-metal hip arthroplasties.Bull nyu hosp jt dis.2011;69 suppl 1:s20-6.Nikolaou vs, petit a, debiparshad k, huk ol, zukor dj, antoniou j.Metal-on-metal total hip arthroplasty - five- to 11-year follow-up.Bull nyu hosp jt dis.2011;69 suppl 1:s77-83.

• Brand Name: FMP HIP
• Type of Device: FMP HEMISPHERICAL SHELL, 3 SCREWHOLE CLUSTER 56MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 4342585
• MDR Text Key: 19762711
• Report Number: 1644408-2014-00789
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2014

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: Health Professional
• Device Expiration Date: 12/31/2012
• Device Catalogue Number: 430-01-056
• Device Lot Number: 53890129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2007
• 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): Required Intervention
• Patient Age: 67 YR