MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pulmonary Embolism (1498); Hematoma (1884); Unspecified Infection (1930); Myocardial Infarction (1969); Renal Failure (2041); Thrombosis (2100); Tissue Damage (2104); Joint Dislocation (2374); No Code Available (3191)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Literature article received entitled "nutritional status and short-term outcome of hip arthroplasty".Literature article entitled, ¿nutritional status and short-term outcome of hip arthroplasty¿ by jamie a.Nicholson, et al, published in the journal of orthopaedic surgery (2012), vol.20, no.3, pp.331-335 was reviewed for mdr reportability.The purpose of this article is to review the nutritional status and outcome of 90 patients who underwent tha or hemiarthroplasty.Records of 51 women and 39 men aged 26 to 96 (median, 71) years who underwent elective tha (n=48) using an uncemented femoral stem (corail; depuy) for osteoarthritis, or trauma-related tha (n=10) or hemiarthroplasty (n=32) for subcapital femoral neck fractures using an uncemented femoral stem were retrospectively reviewed.Nutritional status was assessed using hematological markers of serum albumin (alb) level and total lymphocyte count (tlc).Samples were taken on the day of the operation and within 24 hours of operation.Suboptimal nutrition was defined as a serum alb level of <3.5 g/dl and a tlc of <1.50 cells/mm.Eight patients sustained intra-operative fractures of the femoral canal; 7 of whom were treated with a charnley cable.Their preoperative nutritional levels were lower (but not significantly).14 patients developed postoperative complications (myocardial infarctions, pulmonary embolism, acute renal failure, deep vein thrombosis, urinary tract infection, pressure sore, paralytic ileus, peri-prosthetic fracture following a fall, recurrent dislocation, early subsidence of the graft, hematoma, and wound infections).Their preoperative nutritional levels were also lower (but not significantly).Male gender, old age, and presenting with trauma were risk factors for suboptimal nutritional levels, as gauged by serum alb and tlc values.Co-morbidities did not affect such surrogates of nutritional levels.The individual patient harms were no identified by patient in this article.There were no acetabular components listed within the text.The article only reviews the corail stem implanted in each primary tha.No revisions were recorded, only patient harms intra- and postoperatively.There were several serious injuries that required medical intervention.

Manufacturer Narrative

(b)(4).No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8982380
• MDR Text Key: 161714634
• Report Number: 1818910-2019-103678
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/06/2019
• 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): Hospitalization; Required Intervention