• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR LINERS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nerve Damage (1979); Loss of Range of Motion (2032); Thrombosis (2100); Joint Dislocation (2374); No Code Available (3191)
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 "direct two-incision total hip replacement without fluoroscopy". "literature article entitled, ¿direct two-incision total hip replacement without fluoroscopy¿ by john f irving, md, published by orthopedic clinics of north america (2004), vol. 35, pp. 173-181 was reviewed for mdr reportability. This article reports the success and complications following a two-incision thr that was developed to maximize immediate wbat using current cemented and uncemented implants. It has been used by this author on all patients having a thr since august 2001. The goals were to (1) prepare and insert the components directly axially, (2) completely spare the abductors, (3) spare the fascia lata complex, (4) not require fluoroscopy for implant positioning, and (5) be applicable to all patients and all implants. Though smaller incisions were expected, cosmetic result was not a criterion. Patients were expected to recover faster with fewer complications and to progress with rehabilitation. Hip stability was ensured by proper component placement and sparing of musculotendinous groups. Please see article for detailed, step-by-step instructions of the surgical procedure. From august 2001 through august 2003 all patients undergoing thr with the diagnosis of osteoarthritis were done by the two-incision procedure outlined. There were 142 unilateral procedures. There were 75 men and 67 women. During the same time period, 25 patients (13 men and 12 women) had simultaneous bilateral thr. The average patient weight was 78. 7 kg (range, 45. 9¿159 kg), average height 166. 6 cm (range, 127¿193 cm). Average bmi was 28. 4 (range, 17. 4¿46. 0). Pinnacle (depuy; warsaw, in) porous coated cups were used in all cases with average diameter 54 mm (range, 48¿66 mm). All liners were marathon (de-puy) highly crossed-linked polyethylene. Fifty-one neutral and 91 10 lipped or elevated liners, 28 mm id, were inserted. The femoral stems used were 19 cemented stems, and 123 uncemented stems including 78 s-rom (depuy), 31 summit (depuy) proximal porous coated, and 14 ha corail (depuy) stems. No components have been revised for loosening (follow-up, 6 weeks to 2 years). Acetabular component angles on ap and cross-table lateral films were satisfactory in all but one patient. Intraoperative proximal femoral cracks occurred in five hips during implant insertion (two s-rom, two corail, and one summit). Two thigh dvts were diagnosed within 6 weeks of surgery and were treated with extended warfarin therapy. No anterior wound infections occurred, but three superficial posterior infections occurred with partial dehiscence in one patient. One patient was successfully treated with local wound care. Two patients required secondary closure in the office after the infection cleared. There were no deep infections. One hematoma occurred, requiring readmission for transfusion. One case of grade 4 heterotopic bone developed in a (b)(6) year-old man with a postoperative mi/cva. Three patients reported transient numbness in the distribution of the lateral femoral cutaneous nerve. Leg length discrepancy has been minimal and has not exceeded 8 mm. Three anterior dislocations occurred in the first 50 patients, all with a neutral acetabular liner. Two patients were stable after closed reduction and bracing, one (b)(6) year-old woman required revision of the neutral liner to a 10 lipped liner placed anteriorly to achieve stability. The author did not differentiate patient harms to specific depuy products within the text of this article. There are two individual cases reported within the text labeled as case 1 case 2".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key9008744
MDR Text Key162277083
Report Number1818910-2019-104158
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2019
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 Treatment Data
Date Received: 09/12/2019 Patient Sequence Number: 1
-
-