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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Per internal procedures, the event information was reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Investigational inputs were requested as indicated per internal procedures for this failure mode.Visual examination of the provided x-ray image found no evidence of implant fracture, disassociation, or anything indicative of a device non-conformance.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.

Event Description

"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 prepare and insert the components directly axially, completely spare the abductors, spare the fascia lata complex, not require fluoroscopy for implant positioning, and 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." additional event description to add: case 1 of 2: (b)(6)-year-old man requiring revision for grade 4 heterotopic ossification.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9013657
• MDR Text Key: 159931041
• Report Number: 1818910-2019-104281
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention